Device Events NOU

MASTER_RECORD_KEY|DATE_OF_EVENT|CLASS|GENERIC_NAME|MODEL_NUMBER|BRAND_NAME|
EVENT_TYPE|PROBLEM_TYPE|DOP_TEXT|AMN_TEXT
3502341|20131006|NOU|Continuous, Ventilator, Home Use|100|TRILOGY|Death|Adverse
Event Without Identified Device or Use Problem|ON (B)(6) 2013, AT 9:10AM, RSVP
PERSONNEL SPOKE TO PT'S MOTHER WHO STATED THAT PT (HER SON) PASSED AWAY ON (B)(6)
2013. MOTHER STATED THAT PT'S FATHER PUT PT DOWN FOR A NAP AROUND 3PM. MOTHER WENT
TO CHECK ON PT APPROX 4:15-4:30PM AND HE WAS UNRESPONSIVE. MOTHER STATED PT WAS
NAPPING IN A PACK N PLAY AND HAD DECANNULATED HIMSELF. PT WAS ON ONE END OF PACK N
PLAY AND HIS TRACHEOSTOMY TUBE AT THE OTHER END STILL ATTACHED TO THE VENTILATOR
CIRCUIT. MOTHER STATED THAT THE SIMV RATE WAS SET AT 12. MOTHER ALSO STATED THAT
VENTILATOR WAS NOT ALARMING. MOTHER STATED THAT VENTILATOR STARTED TO ALARM ONCE
SHE DISCONNECTED THE TRACHEOSTOMY TUBE FROM THE VENTILATOR CIRCUIT. MOTHER WAS
ASKED BY RSVP PERSONNEL IF THE PULSE OXIMETER WAS ALARMING AND MOTHER STATED THAT
THE PULSE OXIMETER HAD NOT BEEN PLACED ON THE PT. MOTHER STATED THAT BETWEEN DRS.
(B)(6), SHE WAS TOLD THAT THE PULSE OXIMETER COULD BE USED AS NEEDED DURING THE
DAY, SO IT WAS NOT ON THE PT. MOTHER WILL CALL TO ARRANGE A TIME FOR USE TO PICK UP
THE EQUIPMENT.|
4151986|20140704|NOU|Continuous, Ventilator, Home Use|HT50|HT50 VENTILATOR|Injury|
Power Problem|IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT ARRIVED TO THE
HOSPITAL FOR RESPITE CARE BY TAXI; WHILE BEING VENTILATED ON AN HT50 VENTILATOR.
THE HT50 VENTILATOR WAS REPORTED TO HAVE BEEN PLUGGED INTO THE TAXI'S LIGHTER
RECEPTACLE FOR THE DURATION OF THE TRIP WHICH WAS REPORTED TO BE ABOUT AN HOUR.
UPON ARRIVAL TO THE HOSPITAL THE STAFF NOTICED THE VENTILATOR WAS NOT VENTILATING
THE PATIENT. THE STAFF NOTICED THE LIGHT EMITTING DIODE (LED) OF THE EXTERNAL
BATTERY WAS ILLUMINATED. THE PATIENT WAS REMOVED FROM THE DEVICE AND AMBU BAGGED
DURING TRANSFER FROM THE TAXI TO THE HOSPITAL. ONCE ENTERING THE HOSPITAL THE HT50
WAS REBOOTED AND PLACED BACK ON THE PATIENT. AFTER REMOVING THE PATIENT FROM THE
ELEVATOR THE STAFF NOTICED THE VENTILATOR STOPPED CYCLING WITH THE ALARM LED
ILLUMINATED. THE VENTILATOR CIRCUITS WERE CHECKED FOR LEAKS HOWEVER NONE WERE
FOUND. IN ADDITION, THE MANOMETER WAS FOUND NOT TO BE FUNCTIONING AT THIS TIME. THE
PATIENT WAS AGAIN AMBU BAGGED UNTIL A FAMILY MEMBER OF THE PATIENT REBOOTED THE
VENTILATOR.|IT WAS REPORTED THAT A COVIDIEN SALES REPRESENTATIVE INSPECTED THE
DEVICE AND NO ANOMALIES WERE FOUND. ADDITIONALLY, THE CIRCUIT AND OXYGEN BLENDING
KIT WAS CHECKED, NO ANOMALIES WERE FOUND. THE DEVICE WAS REPORTED TO BE
CONTINUOUSLY USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM REPORTED. THE PATIENT
WAS REPORTED TO REMAIN ON THE DEVICE FOR CONTINUOUS VENTILATION. NO ADDITIONAL
INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. (B)(4).
4181807||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|Malfunction|Device
Displays Incorrect Message|(B)(4).|THE DEVICE WAS BEING USED FOR DEMONSTRATION
PURPOSES AT THE TIME THE FAULT OCCURRED. RESMED HAS REQUESTED FOR THE DEVICE TO BE
RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS
NOT BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION
AT THIS TIME. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT.
4181881|20140801|NOU|Continuous, Ventilator, Home Use|27003|ASTRAL 150 - AMER|
Malfunction|Device Displays Incorrect Message|A RESMED EMPLOYEE WAS DEMONSTRATING
THE ASTRAL VENTILATOR AND OBSERVED A SYSTEM FAULT DISPLAYING "VENTILATION STOPPED
RETURN FOR SERVICE". THE DEVICE WAS NOT ON A PATIENT AT THE TIME THE FAULT WAS
OBSERVED. REFERENCE MFR #3004604967-2014-00020.|
4224655||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|Malfunction|Image
Display Error / Artifact|REFERENCE IMP #(B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE.
THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
4224658||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|Device
Displays Incorrect Message|REFERENCE IMP #(B)(4).|THE DEVICE IS CURRENTLY BEING
RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING
INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINISHED
AT THIS STAGE. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS FAILURE MODE HAVE BEEN
ASSESSED AND DO NOT WARRANT A RECOMMENDATION TO TAKE ANY IMMEDIATE CORRECTIVE OR
CONTAINMENT ACTIONS. THERE WAS NO PT INJURY FOR THIS INCIDENT.
Malfunction|Image Display Error / Artifact|IT WAS REPORTED TO RESMED THAT THE LCD
TOUCH SCREEN WAS NOT RESPONSIVE. THERE WAS NO ALLEGATION THAT THE PT'S THERAPY WAS
INTERRUPTED. REFERENCE MFR #3004604967-2014-00030.|
4224661||NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DBL KIT FRA|
Malfunction|Device Displays Incorrect Message|DURING THE TECHNICAL SERVICE
EVALUATION THE DIAGNOSTIC LOGS WERE EVALUATED ANF A SYSTEM FAULT WAS DETECTED IN
THE LOG ENTRIES. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE,
THERE WAS NO PT INVOLVEMENT. REFERENCE MFR #3004604967-2014-00028.|
4224671|20140904|NOU|Continuous, Ventilator, Home Use|27052|ASTRAL 100 DEU|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(4) THAT
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. THERE WAS NO ALLEGATION THAT THE
PATIENT'S THERAPY WAS INTERRUPTED. REFERENCE MFR #3004604967-2014-00024.|
Malfunction|Device Displays Incorrect Message|A RESMED EMPLOYEE WAS DEMONSTRATING
THE ASTRAL VENTILATOR AND OBSERVED A SYSTEM FAULT DISPLAYING "VENTILATION STOPPED
RETURN FOR SERVICE". THE DEVICE WAS NOT ON A PT AT THE TIME THE FAULT WAS OBSERVED.
REFERENCE: MFR #3004604967-2014-00023.|
4224675||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DBL KIT FRA|Malfunction|
Device Displays Incorrect Message|REFERENCE IMP # (B)(4).|THE DEVICE WAS EVALUATED
AND THE SYSTEM FAILUT DID NOT RECUR. THE DEVICE PASSED ALL TESTING AND WAS RETURNED
TO THE CUSTOMER. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS FAILURE MODE HAVE
BEEN ASSESSED AND THERE IS NO PT SAFETY RISK ASSOCIATED WITH THIS FAULT. THERE WAS
NO PT INJURY REPORTED FOR THIS INCIDENT.
Displays Incorrect Message|REFERENCE IMP #(B)(4).|THE DEVICE IS CURRENTLY BEING
INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED
AT THIS STAGE. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS FAILURE MODE HAVE BEEN
ASSESSED AND DO NOT WARRANT A RECOMMENDATION TO TAKE ANY IMMEDIATE CORRECTIVE OR
CONTAINMENT ACTIONS. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT.
4232302|20140513|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50 FW2.00|
Malfunction|Insufficient Information|CUSTOMER'S DESCRIPTION: "DURING PLUG-IN OF THE
HOME CARE VENTILATOR UNIT TO THE 220V POWER, A COMPLETE BREAKDOWN OF THE DEVICE
WITHOUT AN ALARM DID OCCUR. DUE TO THE NEUROLOGICAL DISEASE OF THE PT WITH STRONG
REDUCED FUNCTIONALITY OF THE ARM AND BREATHING MUSCULATURE, A STOP OF BREATHING
WOULD HAVE BEEN THE CONSEQUENCE WITHOUT EXTERNAL HELP. THE HYPOXIA COULD BE AVOIDED
BY QUICK AND COMPETENT ACTIONS OF THE PRESENT CAREGIVER". THE DEVICE WAS RETURNED
TO SWEDEN FOR INVESTIGATION ON (B)(4), WITH FIRMWARE VERSION 2.0 AND A TOTAL
OPERATING TIME OF ABOUT 4000 HOURS. THE INVESTIGATION COMPRISED A DETAILED ANALYSIS
OF THE DEVICE LOG FILES, A VISUAL INSPECTION OF THE HARDWARE, A PROVOKING TEST, AS
WELL AS A FULL PRODUCTION TEST IN THE MFG LINE.|UNDER (B)(4) LAW, PT INFO IS
CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE LOG FILE
ANALYSIS CONFIRMED ONE INSTANCE OF ERROR 21 OCCURRED ON (B)(6) 2014. ERROR 21
SIGNALS A COMMUNICATION FAILURE BETWEEN THE DEVICE'S MAIN PROCESSOR AND ITS SENSOR
BLOCK. THE FAILURE HAD OCCURRED DURING TREATMENT RUNNING ON INTERNAL BATTERY AT
13:49 AND THE DEVICE IMMEDIATELY ENTERED THE ACTIVE FAILURE STATE. THE DEVICE WAS
MANUALLY RESTARTED APPROX 3 MINUTES AFTER THE ERROR HAD TRIGGERED THIS FAIL-SAFE
SHUT-DOWN, THIS INDICATING AN INTERMITTENT ERROR. NO OTHER ALARMS WERE TRIGGERED
IMMEDIATELY PRIOR TO THE SHUT-DOWN. DURING THE ALARM PERIOD (FUNCTION FAILURE
ACTIVE), THE VIVO 50 IS DESIGNED TO GIVE AN ALARM SIGNAL BOTH VISUALLY AND AUDIBLE.
THERE ARE 2 BEEPERS FOR REDUNDANCY REASONS CONTROLLED BY THE 2 INDEPENDENT
PROCESSORS, WHICH ARE MONITORING EACH OTHER AND A NUMBER OF SENSORS. IN ADDITION,
BOTH BEEPERS AND THEIR 2 SEPARATE BACK-UP BATTERIES ARE TESTED BEFORE TREATMENT
START. THE ALARM WILL BE ACTIVE FOR 10 MINS OR UNTIL THE POWER BUTTON IS PRESSED.
AN IN-DEPTH LOG FILE ANALYSIS REVEALED THE REASON FOR THE ERROR TO BE TRIGGERED WAS
BECAUSE COMMUNICATION BETWEEN MAIN PROCESSOR AND THE SENSORS' ADC (ANALOG-TO-
DIGITAL CONVERTER) WAS DISTURBED. THE EXACT TRUE ROOT CAUSE COULD NOT BE DETERMINED
SINCE THE FAULT COULD NOT BE REPRODUCED, HOWEVER, AN ESD INDUCED EVENT BEYOND
SPECIFIED LIMITS (PER EN 60601-1-2 AND ASTM F1246-91) CANNOT BE RULED OUT. THE
DEVICE WAS WORKED AS INTENDED AND AS DESIGNED WHEN A COMMUNICATION ERROR IS
DETECTED. THE ERROR, WHICH TRIGGERED A FAIL-SAFE SHUT-DOWN (ERROR CODE #21), WAS
INTERMITTENT AND THE DEVICE COULD BE RESTARTED. THE DEVICE'S LOG FILES CONFIRM THAT
THE TREATMENT SESSION ON (B)(6) HAS ENDED NORMALLY IN AN ACTIVE STATE OF FUNCTIONAL
FAILURE. ANALYSIS OF THE DEVICE HARDWARE DID NOT SHOW ANY EVIDENCE THAT THE DEVICE
STOPPED WITHOUT ALARM. IN FACT, BOTH THE LOG ENTRIES AND THE WORKING HARDWARE ARE
INDICATING THAT THE ALARM WAS INDEED WORKING, BOTH AUDIBLY AND VISUALLY, WHEN THE
FUNCTIONAL FAILURE WITH ERROR CODE #21 OCCURRED. THE ALARM WAS CLEARED MANUALLY VIA
THE POWER ON BUTTON AFTER APPROX 3 MINUTES, ACCORDING TO THE LOG FILES. THE ROOT
CAUSE IS ASSUMED TO BE EXPOSURE TO AN EMC OR ESD EVENT BEYOND DESIGN SPEC LIMITS
(ACCORDING TO EN 60601-1-2 AND ASTM E1246-91), RELEVANT FOR FIRMWARE VERSION FW
2.00 OF THE REPORTED DEVICE, UPGRADING THE VIVO (B)(4) TO A FIRMWARE LATER THAN FW
2.00 WILL PROVIDE BETTER IMMUNITY AGAINST EMC/ESD DISTURBANCES, DUE TO FURTHER
ENHANCEMENTS ABOVE REQUIREMENTS. A NEW FIRMWARE WAS MADE PUBLICLY AVAILABLE ON
11/18/2013, AND HAS BEEN ACTIVELY PROMOTED AS A RECOMMENDED UPGRADE. ALL VIVO (B)
(4) DEVICES SOLD TO US CUSTOMERS HAVE BEEN CONFIGURED AT THE FACTORY WITH A
FIRMWARE LATER THAN (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO PT INJURY
REPORTED FOR THIS INCIDENT. (B)(4).
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO PATIENT
INJURY REPORTED FOR THIS INCIDENT. (B)(4).
Displays Incorrect Message|REF IMPORTER (B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY IN SYDNEY, AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE
INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)
(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO (B)(4) FOR
EVALUATION. THE EVALUATION WAS PERFORMED AND NO FAULT COULD BE FOUND. THERE WAS NO
PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
4291358||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|Device
4291375||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -EUR4|Malfunction|Device
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT A
SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS
IN USE AND ON A PATIENT WHEN THE FAULT OCCURRED. THERE WAS NO PATIENT INJURY
REPORTED FOR THIS INCIDENT. REF MFR 3004604967-2014-00049.|
4291391|20141001|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 - DEU|
A CUSTOMER HAD AN ASTRAL DEVICE WITH A BATTERY INOPERABLE ALARM. THE DEVICE WAS NOT
IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. (B)
(4).|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED (B)(4) THAT
DURING INCOMING INSPECTION, A SYSTEM FAULT OCCURRED. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. (B)(4).|
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE DURING PATIENT THERAPY. REF MFR
3004604967-2014-00035.|
4291516|20141001|NOU|Continuous, Ventilator, Home Use|27063|ASTRAL 150 -EUR4|
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. REF MFR 3004604967-2014-00033.|
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. TE DEVICE WAS NOT USED ON A
PATIENT. ERROR OCCURRED AT THE DISTRIBUTOR SITE. REFERENCE MFR # 3004604967-2014-
00027.|
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY (B)(4) AND IS BEING
RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT.
4297934||NOU|Continuous, Ventilator, Home Use|27001|ASTRAL 100 - AMER|Malfunction|
Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT A SYSTEM FAULT WAS
OBSERVED ON AN ASTRAL DEVICE. PER THE REPORTER, THE PT GOT UP WHILE STILL CONNECTED
TO THE DEVICE AND SPILLED WATER INTO THE VENTILATOR. SHE THEN TURNED OFF THE DEVICE
AND WHEN SHE TURNED IT BACK ON, IT NOW SHOWS SYSTEM FAULT 75. MFR #: 3004604967-
2014-00040.|
4342030||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - EUR2|Malfunction|Power
Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR
AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS
INCIDENT. (B)(4).
4342054||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC|Malfunction|
Failure to Charge|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN
RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS
TIME. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
4342069||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|No
Display / Image|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT
AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN
No Display / Image|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
No Display / Image|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN
(B)(4)FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO PATIENT INJURY REPORTED
FOR THIS INCIDENT. (B)(4).
4342161||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 - EUR4|Malfunction|Device
4342168||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SGL KIT - FRA|
Malfunction|Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO
THE RESMED (B)(4) TECHNICAL CENTER. DURING THE EVALUATION OF THE DEVICE A SYSTEM
FAULT WAS FOUND IN THE DOWNLOADED ERROR LOGS. THE DEVICE WAS RETURNED TO THE
THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE
THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT.
Displays Incorrect Message|REF IMPORTER 3007573469-2014-00018.|THERE WAS NO PATIENT
INJURY REPORTED FOR THIS INCIDENT. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS
FAILURE MODE HAVE BEEN ASSESSED AND THERE IS NO PATIENT SAFETY RISK ASSOCIATED WITH
THIS FAULT. THE DEVICE IS BEING RETURNED TO THE MANUFACTURING FACILITY IN (B)(4)
FOR AN ENGINEERING INVESTIGATION. (B)(4).
Displays Incorrect Message|REF IMPORTER 3007573469-2014-00023.|THE DEVICE WAS
THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE.
4342264||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SC - DEU|Malfunction|
Device Displays Incorrect Message|REF IMPORTER 3007573469-2014-00047.|THE DEVICE
WAS RECEIVED BY RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. A
PRELIMINARY RISK ANALYSIS HAS CONCLUDED THAT THE PATIENT SAFETY RISK IS ACCEPTABLE.
(B)(4).
Displays Incorrect Message|REF IMPORTER 3007573469-2014-00045.|THE DEVICE WAS
RECEIVED BY RESMED CORP IN (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
4342309||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|Power
Problem|REF IMPORTER 3004604967-2014-00057.|THE DEVICE WAS RECEIVED BY RESMED (B)
(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).
Malfunction|Device Inoperable|REF IMPORTER 3007573469-2014-00049.|THE DEVICE WAS
Malfunction|Failure to Charge|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. A PRELIMINARY RISK ANALYSIS HAS
CONCLUDED THAT THE PATIENT SAFETY RISK IS ACCEPTABLE. THE INVESTIGATION METHODS,
4342446|20141001|NOU|Continuous, Ventilator, Home Use|27083|ASTRAL 150 - APAC|
Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED (B)(4) THAT THE BATTERY IN
THE ASTRAL DEVICE WILL NOT FULLY CHARGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR 3004604967-2014-
00045.|
4342450|20141001|NOU|Continuous, Ventilator, Home Use|27023|ASTRAL 150 - EUR2|
Malfunction|Power Problem|IT WAS REPORTED BY RESMED (B)(4) THAT DURING INCOMING
INSPECTION, THE POWER SUPPLY UNIT WAS NOT WORKING. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR
3004604967-2014-00044.|
4342489|20141001|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DBL KIT FRA|
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT A BAR APPEARED
ON THE SCREEN OF AN ASTRAL DEVICE. THERE WAS NO ALLEGATION THAT THE PATIENT'S
THERAPY WAS INTERRUPTED OR THAT THE DEVICE FAILED TO PROVIDE APPROPRIATE
VENTILATION. REF MFR 3004604967-2014-00043.|
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE TOUCHSCREEN DISPLAY WAS SWITCHING BETWEEN NORMAL SCREEN AND WHITE SCREEN.
THERE WAS NO ALLEGATION THAT THE PATIENT'S THERAPY WAS INTERRUPTED OR THAT THE
DEVICE FAILED TO PROVIDE APPROPRIATE VENTILATION. REF MFR 3004604967-2014-00042.|
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT THE TOUCH
SCREEN OF AN ASTRAL DEVICE DRIFTED ON THE RIGHT. THERE WAS NO ALLEGATION THAT THE
PATIENT'S THERAPY WAS INTERRUPTED. REF MFR 3004604967-2014-00041.|
THE ASTRAL DEVICE REBOOTS WHEN VENTILATION IS STARTED. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO PATIENT INVOLVEMENT. REF MFR
3004604967-2014-00037.|
4342622|20141001|NOU|Continuous, Ventilator, Home Use|27072|ASTRAL 100 SGL KIT -
FRA|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(4)
THAT WHILE SETTING UP AN ASTRAL DEVICE IT REMAINED ON THE RESMED START-UP SCREEN.
REF MFR 3004604967-2014-00036.|
SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. THERE WAS NO ALLEGATION THAT THE
PATIENT'S THERAPY WAS INTERRUPTED. REF MFR 3004604967-2014-00025.|
4342693||NOU|Continuous, Ventilator, Home Use|27052|ASTRAL 100 DEU|Malfunction|
Device Displays Incorrect Message|IT WAS REPORTED BY RESMED (B)(4) THAT DURING
INCOMING INSPECTION, A SYSTEM FAULT OCCURRED. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR 3004604967-
2014-00029.|
THE BATTERY IN THE ASTRAL DEVICE WILL NOT FULLY CHARGE. THE DEVICE REMAINED
OPERATIONAL AND THE PATIENT'S VENTILATION THERAPY WAS NOT INTERRUPTED. REF MFR
3004604967-2014-00034.|
SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE WHEN VENTILATION WAS STARTED. THERE
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR 3004604967-
2014-00056.|
4342728|20141101|NOU|Continuous, Ventilator, Home Use|27051|ASTRAL 100 SC - DEU|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK FAULT. THE
DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT. REF MFR 3004604967-2014-00058.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE POWER SUPPLY ON
AN ASTRAL DEVICE FAILED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. REF MFR 3004604967-2014-00057.|
FRA|Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED (B)(4) THAT THE
INTERNAL BATTERY WAS NOT CHARGING FOR AN ASTRAL DEVICE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-2014-00062.|
FRA|Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE
SETTING UP AN ASTRAL DEVICE, THE SCREEN WAS BLACK AND THERE WAS AN AUDIBLE ALARM.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT. REF MFR 3004604967-2014-00060.|
FRA|Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED FRANCE THAT AN ASTRAL
DEVICE'S INTERNAL BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604867-2014-00063.|
FRA|Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE'S INTERNAL BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE
MEASUREMENT MAY BE INCORRECT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. REFERENCE MFR # 3004604967-2014-00059.|
4355752||NOU|Continuous, Ventilator, Home Use||ASTRAL 150-DEU|Injury|Use of Device
Problem|IMP REF#: (B)(4).|NO DEVICE WAS RETURNED RESMED FOR INVESTIGATION. THERE
WAS NO REPORT OF A DEVICE MALFUNCTION. PER THE CUSTOMER, ALL ALARMS WERE
INDIVIDUALLY SWITCHED OFF, THE SPECIFIC MENTION THAT "DISCONNECTION ALARM /
HYPOVENTILATION ALARM WERE SWITCHED OFF". WHEN ALL THE ALARMS ARE DEACTIVATED, THE
DEVICE WILL NOT ALARM WHEN THE PATIENT CIRCUIT IS DISCONNECTED. THE ASTRAL USER
GUIDE SPECIFICALLY STATES UNDER "CAUTION" THAT "ALARMS SHOULD BE CONFIGURED AND
TESTED TO ENSURE THAT CIRCUIT DISCONNECTION AND DECANNULATION IS DETECTED".
4356207|20140916|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150-DEU|Injury|
Use of Device Problem|IT WAS REPORTED TO RESMED GERMANY THAT A PATIENT BEING
VENTILATED ON AN ASTRAL DEVICE WAS FOUND MOTIONLESS WITH A CARDIAC ARREST. PER THE
REPORTER, "DURING THE ROUTINE VIGILANCE ROUND BY THE CLINICIAN THE PATIENT WAS
FOUND DISCONNECTED FROM THE VENTILATOR BREATHING SYSTEM, MOTIONLESS WITH A CARDIAC
ARREST. IMMEDIATE INITIATED RESUSCITATION WITH DEFIBRILLATION WAS SUCCESSFUL. THE
PATIENT WAS BEING VENTILATED IN AN NIV MODE WITH THE DISCONNECTION ALARM / HYPO-
VENTILATION ALARM SWITCHED TO THE OFF POSITION RESULTING IN NO ALARM SIGNAL
INITIATED WHEN THE DISCONNECTION OF THE PATIENT OCCURRED". MFR REF#: 3004604967-
2014-00026.|
Device Displays Incorrect Message|IMP REF# (B)(4).|THE DEVICE WAS RETURNED TO THE
(4).
4369851|20141013|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS|Malfunction|
Device Inoperable;Device Stops Intermittently|CUSTOMER'S DESCRIPTION: THE DEVICE
STOPPED AND STARTED THE THERAPY SEVERAL TIMES BETWEEN 5:40 AM AND 5:50 AM. FINALLY
IT STOPPED AT 5:50:40. THE DEVICE DID NOT GIVE ALARMS (BECAUSE THE UNIT TURNED
ITSELF OFF). THE NURSING STAFF STARTED THE VIVO AGAIN AT 5.45 MANUALLY - THE DEVICE
DID NOT STOP AND DID NOT CREATE PROBLEMS TILL 11:50 AM. A TECHNICIAN WAS GOING TO
CHECK THE VIVO AT 11:51:30. THE DEVICE WAS RUNNING AT THAT TIME BUT DID NOT REACT
ANYMORE BY PRESSING THE BUTTONS ON/OFF.|UNDER (B)(6) LAW, PT INFO IS CONSIDERED
CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. ANOTHER DEVICE, S/N (B)(4),
WITH A SIMILAR PROBLEM WAS REPORTED AT THE SAME TIME. (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED GERMANY
THAT DURING INCOMING INSPECTION, A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE
INDICATING A SOFTWARE TASK ERROR. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MFR REPORT# 3004604967-2014-
00065.|
4379758||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|No
Display / Image|(B)(4)|THE DEVICE WAS EVALUATED BY A RESMED SERVICE TECHNICIAN AT
THE USER FACILITY. IT WAS FOUND THAT THE TOUCH SCREEN ON THE DEVICE WAS NOT
RESPONDING. THE VENTILATOR TOP CASE WAS REPLACED TO ADDRESS THE ISSUE. (B)(4).
DEVICE'S TOUCHSCREEN DISPLAY WAS NOT RESPONDING. THERE WAS NO REPORTED HARM OR
INJURY TO THE PT. REF MFR# 3004604967-2014-00066.|
DURING INCOMING INSPECTION, THE ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-
TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT
INVOLVEMENT. REF MFR # 3004604967-2014-00069.|
WHILE SETTING UP AN ASTRAL DEVICE, THE DEVICE FAILED TO PASS ITS INTERNAL SELF-
4379875||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|Failure
of Device to Self-Test|(B)(4)|THE DEVICE WAS RETURNED TO THE MFG FACILITY IN (B)(4)
FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED (B)(4).
4379876|20141101|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DOL KIT FRA|
DURING INCOMING INSPECTION OF AN ASTRAL DEVICE, A DEVICE SERVICE TEST FAILED. THE
DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK ERROR. THERE
WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR #
3004604967-2014-00073.|
Power Problem|(B)(4)|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN (B)
Failure to Power Up|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
Displays Incorrect Message|(B)(4).|(B)(4). A PRELIMINARY RISK ANALYSIS HAS
CONCLUDED THAT THE PATIENT SAFETY RISK IS ACCEPTABLE. THE INVESTIGATION METHODS,
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL
DEVICE WILL NOT START. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR REPORT 3004604967-2014-00067.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL DEVICE
HAD A POWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. REF
MFR REPORT 3004604967-2014-00071.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK ERROR. THERE
WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR REPORT
3004604967-2014-00072.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE. THERE WAS NO HARM OR INJURY REPORTED.
MFR REF # 30046049672014-00064.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK ERROR. THE
DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT
INVOLVEMENT. MFR REF # 3004604967-2014-00074.|THE DEVICE WAS RETURNED TO THE MFG
AN ASTRAL DEVICE HAD A SYSTEM FAULT. THERE WAS NO PT INJURY REPORTED FOR THIS
INCIDENT. MFR REF # 300460497-2014-00075.|
4420325|20141201|NOU|Continuous, Ventilator, Home Use|27064|ASTRAL 150 DBL KIT -
EUR4|Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED ITALY THAT AN ASTRAL
DEVICE DOES NOT SWITCH ON. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF
THIS INCIDENT. MFR REF # 3004604967-2014-00077.|
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(6) THAT DURING THE
DISTRIBUTOR'S INCOMING INSPECTION, THE ASTRAL DEVICE STOPPED AND THE SCREEN FORCE.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT
INVOLVEMENT. MFR REF # 3004604967-2014-00078.|
4420973|20141201|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -EUR4|
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED (B)(4) THAT THE POWER
SUPPLY ON AN ASTRAL DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).|THE POWER SUPPLY UNIT WAS RETURNED
TO THE MANUFACTURING FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
RESMED REFERENCE: (B)(4).
4420993||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|Battery
Problem|(B)(4).|THE DEVICE WAS EVALUATED AND IT WAS FOUND THAT THE BATTERY WAS NOT
CHARGING. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED RISK ANALYSIS FOR
THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
4420995||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -EUR4|Malfunction|Failure
to Power Up|(B)(4)|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN
ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED,
THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
Sensing Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED (B)(6) THAT THE POWER
SUPPLY ON AN ATRIAL DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR REF #3004604967-2015-00001.|
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL
DEVICE'S BATTERY IS NOT CHARGING. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR REF #30046044967-2015-00004.|
4421196|20141201|NOU|Continuous, Ventilator, Home Use|27063|ASTRAK 150 -EUR4|
DEVICE HAD A POWER FAILURE WHILE PERFORMING A SELF-TEST. THE POWER FAILURE OCCURRED
DURING THE DEVICE START-UP. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR REF #3004604967-2015-00002.|
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE. THERE WAS NO PATIENT HARM OR
INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR REF #3004604967-2015-00003.|
Malfunction|Device Sensing Problem|IT WAS REPORTED TO RESMED THAT THE THERAPIST WAS
UNABLE TO CONFIGURE THE BREATH SYNCHRONIZING FEATURE (TRIGGERING) ON THE ASTRAL
VENTILATOR. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR REF #3004604967-2015-00005.|
Device Alarm System|REF IMP (B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).
Displays Incorrect Message|REF IMP (B)(4).|THE DEVICE WAS RETURNED TO THE
(4).
Sensing Problem|REF IMP (B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO
4436769||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC|Malfunction|Device
(4).
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED FRANCE THAT AN ASTRAL
DEVICE'S SCREEN WENT BLACK AND AN AUDIBLE ALARM SOUNDED. THERE WAS NO PATIENT HARM
OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR 3004604967-2015-00006.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE. THE DEVICE WAS NOT USED ON A PATIENT
WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR
3004604967-2015-00007.|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED UNITED
KINGDOM THAT A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE. REF MFR 3004604967-2015-
00009.|
Malfunction|Device Sensing Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DID NOT DISPLAY THE PATIENT TIDAL VOLUME READING (VTE) WHILE THE PATIENT WAS BEING
SETUP ON THE VENTILATOR. REF MFR 3004604967-2015-00012.|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY A RESMED ACCOUNT
MANAGER THAT WHILE DEMONSTRATING A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE
INDICATING THE DEVICE WAS OUT OF CALIBRATION. THE DEVICE WAS NOT ON A PATIENT WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REF MFR
3004604967-2015-00008.|
4436915|20141201|NOU|Continuous, Ventilator, Home Use|27083|ASTRAL 150 - APCC|
A SYSTEM FAULT OCCURRED IN AN ASTRAL DEVICE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED FOR THIS INCIDENT. REF MFR 3004604967-2015-00011.|
Problem|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS EVALUATED AND IT WAS FOUND THAT
THE BATTERY WAS NOT CHARGING. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE.
RESMED RISK ANALYSIS FOR THIS FAILURE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)
(4).
DEVICE'S BATTERY WAS NOT CHANGING. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS
RESMED GERMANY AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
AN ERROR MESSAGE INDICATING BATTERY FAULT WAS DISPLAYED AND THEN ASTRAL DEVICE
RESTARTED. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. REFERENCE MFR # 3004604967-2015-00013.|
Device Inoperable|(B)(4)|(B)(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT THE DISPLAY
SCREEN WAS FLICKERING IN AN ASTRAL DEVICE AND THE DEVICE BECAME INOPERABLE. THERE
WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR
# 3004604967-2015-00014.|
Device Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS
AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDE THAT THE
RISK IS ACCEPTABLE. (B)(4). NOTE: THE REPORTABLE EVENT OCCURRED OUTSIDE THE US AND
WAS ACCESSED AS NOT REPORTABLE IN (B)(6). DURING A ROUTINE CHECK OF COMPLAINTS
RECORDS IT WAS DETECTED THAT THE EVENT IS REPORTABLE IN THE US. THIS REPORT IS
BEING SUBMITTED TO CORRECT THE ERROR.
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED FRANCE THAT
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES 101 AND 218. ERRORS 101 AND 218 RESULT IN
AN ALARM WHICH NOTIFIES CAREGIVERS TO THE MALFUNCTION. THERE WAS NO PATIENT HARM OR
INJURY REPORTED FOR THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00015.|
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE CUSTOMER REPORTED THAT
THE PATIENT DROPPED THE DEVICE CAUSING THE VALVE ADAPTER IN THE ASTRAL DEVICE TO
DISCONNECT AND DISPLAY THE ERROR MESSAGE. THE VALVE ADAPTER WAS REINSTALLED TO
RESOLVE THE ERROR. THE DEVICE WAS NOT RETURNED TO RESMED. RESMED'S RISK ANALYSIS
FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE AFTER BEING DROPPED. THE DEVICE WAS NOT ON
A PATIENT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
REFERENCE MFR # 3004604967-2015-00017.|
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE
MEASUREMENT MAY BE INCORRECT. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR # 3004604967-2015-00016.|
Displays Incorrect Message|IMP# (B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4)
AND IT IS CURRENTLY BEING RETURNED TO THE MFG FACILITY LOCATED IN (B)(6) FOR AN
ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE
NOT FINALIZED AT THIS STAGE. (B)(4).
4489990||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|Malfunction|
Detachment Of Device Component|(B)(4).|THE DEVICE WAS NOT RETURNED FOR
INVESTIGATION. THERE WAS NO DEVICE MALFUNCTION AND THE DEVICE OPERATED AS DESIGNED.
PER THE REPORTER, THE EXPIRATORY VALVE BLOCK WAS REINSERTED INTO THE DEVICE AND
NORMAL VENTILATION WAS RESTORED. (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY THE MFR AND AN
ENGINEERING INVESTIGATION WAS PERFORMED. A REVIEW OF THE DEVICE DATA CONFIRMED ONE
OCCURRENCE OF SYSTEM FAULT 188 (NOT 118 AS INITIALLY REPORTED) AND SYSTEM FAULT
218. AN EXTENSIVE INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE. THE STRESS
TEST TO REPLICATE THE FAULT AS WELL AS A VISUAL INSPECTION OF THE RETURNED PRODUCT
CONFIRMED THE DEVICE OPERATED AS DESIGNED. BASED ON ALL AVAILABLE EVIDENCE, THE
ROOT CAUSE OF THE ONE-OFF OCCURRENCE IS UNK. IT IS POSSIBLE THE FAULT WAS CAUSED BY
A SOFTWARE TIMING ISSUE ON THE PNEUMATIC BLOCK AND MAIN PC BOARD DURING START-UP;
HOWEVER, OUR INVESTIGATION COULD NOT REPRODUCE THE FAULT CONDITION. RESMED'S RISK
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
NOTE: DURING A ROUTINE EVAL OF COMPLAINT RECORDS, IT WAS DETECTED THAT THIS EVENT
IS REPORTABLE IN THE USA. THIS REPORT IS BEING SUBMITTED TO CORRECT THE ERROR.
AN ALARM WHICH NOTIFIES USERS TO THE MALFUNCTION. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
Injury|Detachment Of Device Component|IT WAS REPORTED TO RESMED THAT WHEN THE
CAREGIVER MOVED THE TROLLEY HOLDING THE ASTRAL DEVICE SHE ACCIDENTALLY DISCONNECTED
THE EXPIRATORY VALVE BLOCK CAUSING THE DEVICE TO ALARM AND STOP VENTILATION. THERE
WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. THE PT WAS MANUALLY
VENTILATED WHILE THE DEVICE WAS REASSEMBLED.|
4490019||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|Failure
to Calibrate|PLEASE REFER IMPORTER REPORT #: (B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MFG FACILITY LOCATED IN (B)
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
Displays Incorrect Message|PLEASE REFER IMPORTER REPORT #: (B)(4).|THE DEVICE WAS
RECEIVED BY RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MFG FACILITY
A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A POSITIVE END
EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE. THERE WAS NO PT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|
RETURNED TO THE MFG FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
(B)(4).
SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER FAULT. THERE
WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
RECEIVED BY RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MFG FACILITY
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED GERMANY
THAT AN ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
4512829||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|Power
Problem|(B)(4).|THE PSU WAS EVALUATED BY RESMED (B)(4) TECHNICAL SERVICE AND IT WAS
FOUND THAT THE PSU WAS NOT WORKING. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE. (B)
(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN STRAL
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00025.|
No Display / Image|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IT IS
CURRENTLY BEING RETURNED TO THE MFR FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING
AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. (B)(4).
DEVICE'S SCREEN TURNED BLACK. THERE WAS NO PT HARM OR INJURY REPORTED FOR THIS
INCIDENT. MFR#: 3004604967-2015-00027.|
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IT
IS CURRENTLY BEING RETURNED TO THE MFG FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN
AN ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR#: 3004604967-2015-00029.|
4528154||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 Â¿ DEU|Malfunction|Device
Displays Incorrect Message|REF IMPORT REPORT #: (B)(4).|THE DEVICE IS CURRENTLY
BEING RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) SO THAT AN ENGINEERING
INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE,
RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
4528165||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DLB KIT FRA|Malfunction|
Device Alarm System|REF IMPORT REPORT #: (B)(4).|AN ENGINEERING INVESTIGATION WAS
PERFORMED ON THE RETURNED ASTRAL DEVICE. THE INVESTIGATION DETERMINED THE ALARM WAS
DUE TO HARDWARE DAMAGE OBTAINED FORM POWER SURGE CAUSED BY AN ELECTRICAL STORM
(LIGHTENING STRIKE). RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
4528167||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 Â¿ DEU|Malfunction|Device
Displays Incorrect Message|REF IMPORT REPORT #: (B)(4) .|THE DEVICE WAS EVALUATED
BY RESMED (B)(4) TECHNICAL SERVICE. IT WAS CONFIRMED THAT A SYSTEM 180 ERROR
OCCURRED INDICATING A BATTERY FAULT. THE BATTERY WAS REPLACED TO ADDRESSED THE
ISSUE. (B)(4).
4528181||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 Â¿ AMER|Malfunction|
Battery Problem|REF IMPORT REPORT #: (B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO
BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS
NOT YET BEEN RETURNED, THEREFOR RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION
AT THIS TIME. (B)(4).
4528183||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SC Â¿ DEU|Malfunction|
Device Displays Incorrect Message|REF IMPORT REPORT #: (B)(4).|THE DEVICE WAS
AT THIS STAGE. (B)(4).
4528184||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 Â¿ EUR4|Malfunction|
Device Displays Incorrect Message|REF IMPORT REPORT #: (B)(4).|THE DEVICE WAS
RETURNED TO THE MFR FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
RESMED RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE.
(B)(4).
4528196||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 Â¿ AMER|Malfunction|
Failure to Calibrate|REF IMPORT REPORT #: (B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY IN (B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE
PERFORMED. THE DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO
CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
4528197||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 Â¿ DEU|Malfunction|
Failure to Calibrate|REF IMPORT REPORT #: (B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECH SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE
EVALUATION DETECTED AN ISSUE WITH THE CHARGING MANAGEMENT SYSTEM AS WELL AS
CONFIRMING THE FAILURE TO PASS THE INTERNAL SELF-TEST. THE DEVICE WAS RETURNED TO
THE MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING
AT THIS STAGE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED GERMANY
THAT AN ASTRAL DEVICE DISPLAYED ALARM MESSAGES 101 AND 218. THE MESSAGE RESULTED IN
AN ALARM WHICH NOTIFIED THE CAREGIVER TO THE MALFUNCTION. THERE WAS NO PT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR REF NO.: 3004604967-2015-00037.|
VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. REF MFR REPORT NO.: 3004604967-2015-00040.|
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S
BATTERY IS INOPERABLE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR REF NO.: 3004604967-2015-00036.|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED UNITED
KINGDOM THAT AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING A SYSTEM
FAILURE. THIS MESSAGE RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER. THE DEVICE
WAS NOT ON A PT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.
MFR REF NO.: 3004604967-2015-00039.|
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED THAT AN ASTRAL
VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. REF MFR REPORT NO.:
3004604967-2015-00038.|
4528253|20150101|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 Â¿ DEU|
A SYSTEM FAULT (SF180) OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER
FAULT. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR REPORT
#: 3004604967-2015-00030.|
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL
DEVICE SUFFERED A SEVERE POWER SURGE THROUGH THE AC ADAPTOR AS THE RESULT OF AN
ELECTRICAL STORM (LIGHTNING STRIKE). THE POWER SURGE RESULTED IN THE DEVICE
GENERATING AN AUDIBLE ALARM THAT NOTIFIES THE USER OF THE MALFUNCTION. THERE WAS NO
PT HARM OR INJURY REPORTED FOR THIS INCIDENT. REF MFR REPORT NO.: 3004604967-2015-
00034.|
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING A SOFTWARE TASK ERROR AND
POSITIVE END EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE. THE MESSAGE RESULTS IN AN
AUDIBLE ALARM THAT NOTIFIES THE PT AND CAREGIVER. THERE WAS NO PT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR REF REPORT NO.: 3004604967-2015-00035.|
DEVICE ALARMED INDICATING THAT ITS VOLUME WAS NOT WITHIN THE EXPECTED RANGE. THERE
WAS NO PT HARM OR INJURY REPORTED FOR THIS INCIDENT. IMP # (B)(4).|
DEVICE ALARMED INDICATING THAT ITS VOLUME WAS NOT WITHIN THE EXPECTED RANGE. THERE
WAS NO PT HARM OR INJURY REPORTED FOR THIS INCIDENT. MFR # 3004604967-2015-00042.|
Displays Incorrect Message|REF IMPORTER # (B)(4).|THE DEVICE WAS RETURNED TO THE
(4).
4546390||NOU|Continuous, Ventilator, Home Use||BATTERIE EXTERNE ASTRAL|Malfunction|
Charging Problem|REF IMPORTER # (B)(4).|THE EXTERNAL BATTERY WAS RECEIVED BY THE
DEVICE MANUFACTURER AND AN ENGINEERING INVESTIGATION WAS PERFORMED. EXTENSIVE
ENGINEERING INVESTIGATION DETERMINED THAT THE EXTERNAL BATTERY PACK WAS DEFECTIVE.
THE EXTERNAL BATTERY PACK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED RISK ANALYSIS
FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: DURING A
THOROUGH EXAMINATION OF COMPLAINTS RECORDS IT WAS DETECTED THAT THE BATTERY PACK
FAILURE THAT OCCURRED IN (B)(6) IS REPORTABLE IN THE U.S. THIS REPORT IS BEING
SUBMITTED TO CORRECT THE ERROR.
Alarm System|REF IMPORTER # (B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE
NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED
MALFUNCTION AT THIS TIME. (B)(4).
4546400||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|No
Display / Image|REF IMPORTER # (B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4)
TECHNICAL SERVICE FOR EVALUATION. THE EVALUATION CONFIRMED THE TOUCHSCREEN DISPLAY
WAS DAMAGED FROM THE UNIT BEING DROPPED. THE DISPLAY WAS REPLACED TO ADDRESS THIS
ISSUE. (B)(4).
Displays Incorrect Message|REF IMPORTER # (B)(4).|THE DEVICE WAS RECEIVED BY RESMED
(B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN
(B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
AN ALARM WHICH NOTIFIES USERS TO THE MALFUNCTION. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. REF MFR # 3004604967-2015-00031.|
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED THAT AN INTERNAL CIRCUIT
ALARM WAS OBSERVED ON AN ASTRAL DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED. THERE WAS NO PATIENT INJURY REPORTED FOR THIS
INCIDENT. REF MFR # 3004604967-2014-00047.|
DEVICE WAS DROPPED CAUSING DAMAGE TO THE TOUCHSCREEN DISPLAY. PER THE REPORTER, THE
DEVICE WAS OPERATING NORMALLY BEFORE IT WAS DROPPED. THERE WAS NO PATIENT INJURY
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE 101 AND 218. THE MESSAGE RESULTS IN AN
AUDIBLE ALARM THAT NOTIFIES THE PATIENT AND CAREGIVER. THERE WAS NO PATIENT INJURY
4546427|20141101|NOU|Continuous, Ventilator, Home Use|27918|BATTERIE EXTERNE
ASTRAL|Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE'S EXTERNAL BATTERY IS NOT CHARGING. THERE WAS NO PATIENT HARM OR INJURY
REPORTED FOR THIS INCIDENT. REF MFR # 3004604967-2015-00028.|
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|RESMED HAS REQUESTED FOR
THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED.
THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE
ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED GERMANY
THAT AN ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-
2015-00047.|
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE INDICATING A SOFTWARE TASK ERROR.
THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE
# 3004604967-2015-00045.|
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING INCORRECT SETTINGS. THE
MESSAGE RESULTS IN AN AUDIBLE ALARM THAT NOTIFIES THE USER OF THE MALFUNCTION.
THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
REFERENCE MFR # 3004604967-2015-00044.|
RECEIVED BY RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
RESMED (B)(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE.(B)(4).
4551640||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -EUR2|Malfunction|Battery
Problem|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY IN (B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE
DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IT
IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN
4570289|20150101|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DBL KIT FRA|
Malfunction|Appropriate Term/Code Not Available|(B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4) FOR EVALUATION. THE DEVICE IS CURRENTLY BEING RETURNED TO THE
PERFORMED. THE DEVICE HAS NOT YET BEEN RECEIVED THEREFORE, RESMED IS UNABLE TO
CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE INDICTING A SOFTWARE TASK ERROR.
WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF: MFR
#3004604967-2015-00046|
Malfunction|Appropriate Term/Code Not Available|IT WAS REPORTED BY RESMED (B)(4)
THAT AN ASTRAL DEVICE FAILED TO SWITCH SETTINGS. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE THERE WAS NO PT INVOLVEMENT. REF MFR#3004604967-2015-
00050.|
Battery Problem|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT
TIME. (B)(4).
Displays Incorrect Message|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE
SYSTEM FAULT MESSAGES WERE OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET
PRESSURE MEASUREMENT MAY BE INCORRECT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE
CAREGIVER OF THE ERROR MESSAGES. THERE WAS NO PT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. MFR # 3004604967-2015-00052.|
THIS INCIDENT. MFR# 3004604967-2015-00051.|
4578280|20150201|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DDBL KIT
FRA|Malfunction|Battery Problem|IT WAS REPORTED BY RESMED (B)(4) THAT AN ASTRAL
DEVICE'S BATTERY ALARM WAS TRIGGERED. THERE WAS NO PT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR #: 3004604967-2015-00053.|
Device Displays Incorrect Message|IMP.# (B)(4).|THE DEVICE WAS RECEIVED BY RESMED
FRANCE AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN
SYDNEY AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR.#:
3004604967-2015-00049.|
Power Problem|(B)(4)|THE DEVICE WAS RECEIVED BY RESMED (B)(4) TECHNICAL SERVICE FOR
EVALUATION. THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY IN
(B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT
YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION
Appropriate Term/Code Not Available|(B)(4)|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(6) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE
EVALUATION WAS NOT ABLE TO REPRODUCE THE CUSTOMER ISSUE. THERE WAS NO FAILURE
DETECTED IN THE DEVICE. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER EVALUATION.
(B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE EVALUATION WAS
NOT ABLE TO REPRODUCE THE CUSTOMER ISSUE. THE DEVICE IS CURRENTLY BEING RETURNED TO
THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.
(B)(4).
No Display / Image|(B)(4)|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
TIME. (B)(4).
Inoperable|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4)
AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY
AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS EVALUATED BY
RESMED (B)(4) TECHNICAL SERVICE. THE EVALUATION DETERMINED THAT THE SYSTEM ALARM
WAS DISPLAYED BECAUSE THE PATIENT'S CIRCUIT ADAPTER WAS INCORRECTLY ASSEMBLED BY
THE CUSTOMER. (B)(4).
DEVICE TOUCH SCREEN BEGAN TO FLASH AND THE DEVICE SETTINGS AND DATA WERE NOT
ACCESSIBLE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. REFERENCE MFR # 3004604967-2015-00060.|
Malfunction|Power Problem|IT WAS REPORTED BY RESMED (B)(4) THAT AN ASTRAL DEVICE
STOPPED FUNCTIONING WHILE BEING CONFIGURE FOR THE PATIENT. THERE WAS NO PATIENT
HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-
2015-00059.|
Malfunction|Device Inoperable|IT WAS REPORTED BY RESMED (B)(4) THAT A BRAND NEW
ASTRAL DEVICE WILL NOT POWER ON. THE DEVICE WAS NOT ON A PATIENT WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REFERENCE MFR #: 3004604967-
2015-00055.|
Malfunction|Appropriate Term/Code Not Available|IT WAS REPORTED TO RESMED (B)(4)
THAT THE PRESSURE ON AN ASTRAL DEVICE WOULD CHANGE BY ITSELF. THERE WAS NO PATIENT
HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-
2015-00058.|
CAREGIVER OF THE ERROR MESSAGES. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00057.|
4592167|20150201|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150-DEU|
# 3004604967-2015-00054.|
Battery Problem|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED FRANCE TECHNICAL SERVICE
AND A PRELIMINARY EVALUATION WAS PERFORMED. THE EVALUATION WAS NOT ABLE TO
REPRODUCE THE CUSTOMER ISSUE. (B)(4).
No Display / Image|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4) FOR EVALUATION.
THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) SO
THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT YET BEEN
RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS
TIME. (B)(4).
4609744|20150201|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|
Malfunction|Device Displays Incorrect Message;Failure to Calibrate|(B)(4).|THE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY
EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE CUSTOMER REPORTED LEARN
CIRCUIT ISSUE. DURING THE EVALUATION, IT WAS ALSO DISCOVERED THAT THE DEVICE HAD A
'SOFTWARE TASK' ERROR RECORDED IN THE DOWNLOADED ERROR LOGS. THE DEVICE IS
CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA
No Display / Image|(B)(4).|RESMED HAS REQUESTED THE DEVICE BE RETURNED SO THAT AN
Displays Incorrect Message|(B)(4).|RESMED HAS REQUESTED THE REPORTER TO PROVIDE
ADDITIONAL INFO REGARDING THE ALARM. AT THIS POINT WITH THE INFO AVAILABLE, RESMED
IS UNABLE TO CONFIRM ANY ALLEGED MALFUNCTION. NO DEVICE SERIAL NUMBER AS PROVIDED.
RESMED IS WORKING WITH THE CUSTOMER TO GET ADDITIONAL INFO. (B)(4).
Malfunction|Failure to Calibrate;Device Displays Incorrect Message|IT WAS REPORTED
BY RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST (LEARN
CIRCUIT). THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00065.|
DEVICE'S TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO PT HARM OR INJURY REPORTED AS
A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00063.|
DEVICE'S BATTERY IS NOT CHARGING. THIS RESULTED IN A WARNING MESSAGE TO NOTIFY THE
USER OF THE ISSUE. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #30046049967-2015-00064|
DEVICE TOUCHSCREEN BEGAN TO FLASH AND THE DEVICE SETTINGS AND DATA WERE NOT
ACCESSIBLE. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR #3004604967-2015-00056.|
ASTRAL DEVICE TRIGGERED AUDIBLE ALARMS THAT NOTIFIED THE USER OF AN EXPIRATORY
MINUTE VOLUME (MVE) ISSUE. PER THE REPORTER THE PT WAS HAVING PROBLEMS WITH LEAK.
THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00061.|
4610170||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|Malfunction|No
Display / Image|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECHNICAL SERVICE. THE
EVAL CONFIRMED THAT THE DEVICE SCREEN WAS FLASHING. THE DEVICE IS CURRENTLY BEING
(B)(4).
4610172|20150201|NOU|Continuous, Ventilator, Home Use|27003|ASTRAL 150 -AMER|
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S
TOUCH SCREEN WAS FLASHING AND THE DEVICE SETTINGS WERE NOT ACCESSIBLE. THE DEVICE
WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S POWER
SUPPLE WAS BROKEN. THERE WAS NO PT HARM OR INJURY REPORTED ASA RESULT OF THIS
INCIDENT. MFR# 304604967-2015-00066.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S POWER
SUPPLY WAS BROKEN. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. (B)(4).|THE POWER SUPPLY WAS RETURNED TO RESMED CORP IN (B)(4). EVAL
CONFIRMED THAT THE POWER SUPPLY WAS NOT FUNCTIONING DUE TO A DAMAGED POWER CORD.
(B)(4).
4617958||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC1|Malfunction|Power
Problem|(B)(4)|THE POWER SUPPLY WAS RETURNED TO THE MFG FACILITY LOCATED IN (B)(6)
4617960|20150201|NOU|Continuous, Ventilator, Home Use|27083|ASTRAL 150 - APAC1|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL DEVICE'S
POWER SUPPLY WAS DAMAGED. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF
4621139||NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS|Malfunction|Device
Operates Differently Than Expected|BREAS RECEIVED A REPORT FROM MESSER MEDICAL IN
AUSTRIA THAT A VIVO 60 UNIT WAS DELIVERING FEWER BREATHS THAN THE NUMBER OF BREATHS
IN THE SETTING. THE UNIT IN QUESTION WAS SET ON SIMV MODE AND HAD THE FOLLOWING
SETTINGS: PRESSURE 23 MBAR, PEEP 6MBAR, RAMP 2, INSP. TRIGGER 2, TI: 0.5S, SIMV
RATE: 40BPM, PSV 23MBAR, EXP. TRIGGER 4. ALTHOUGH THE UNIT WAS SET TO DELIVER 40
BREATHS PER MINUTE, IT WAS OBSERVED THAT THE UNIT WAS ONLY PROVIDING 20 BREATHS PER
MINUTE. UPON INVESTIGATION AND REVIEW OF THE SETTINGS, IT WAS DETERMINED THAT THE
BEHAVIOR OF THE UNIT WAS CONSISTENT WITH THE DESIGN SPECS. AS NOTED IN THE
INSTRUCTIONS FOR USE FOR THE VIVO 60, AFTER A MANDATORY BREATH, THE UNIT WILL
ALWAYS WAIT AT LEAST ONE SECOND BEFORE A NEW MANDATORY BREATH CAN BE INITIATED IN
THE FOLLOWING SIMV CYCLE. THUS, BECAUSE THE SETTINGS AS DESCRIBED ABOVE DID NOT
ALLOW FOR A FULL SECOND BETWEEN MANDATORY SIMV BREATHS, THE UNIT WAS EFFECTIVELY
BLOCKING EVERY SECOND BREATH, CUTTING THE TOTAL NUMBER OF BREATHS IN HALF. IT WAS
DETERMINED THAT THE VIVO 50 WOULD EXHIBIT THE SAME BEHAVIOR WHEN IN SIMV MODE.|A
FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Decrease in Pressure|CUSTOMER'S DESCRIPTION (TRANSLATED): PATIENT FELT THAT HE DID
NOT GET ENOUGH AIR BUT COULD NOT CONVEY THIS. OXYGEN SATURATION DROPPED TO 30%, AS
HE TURNED GREY IN THE FACE. PATIENT WAS ABOUT TO FAINT BUT RECOVERED WHEN MANUALLY
VENTILATED WITH RESUSCITATION BAG. CARING STAFF DIDN'T HEAR ANY ALERTS OR ALARMS
FROM THE VENTILATOR PRIOR TO THE INCIDENT, BUT ONLY SAW THAT THE INSPIRATORY
PRESSURE INDICATOR BAR WAS NOT MOVING AS EXPECTED. A LARGE AMOUNT OF WATER WAS
FOUND INSIDE THE PATIENT CIRCUIT WHEN IT WAS DETACHED. THE STAFF REPLACED THE
DEVICE AND CONTINUED TREATMENT. AN ACTIVE EXTERNAL HUMIDIFIER WAS USED WITH THE
DEVICE. THERE WAS NO PERMANENT INJURY TO THE PATIENT.|UNDER EUROPEAN LAW, PATIENT
INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.
Stops Intermittently;Device Displays Incorrect Message|(B)(4)|THE DEVICE WAS
RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION WAS NOT ABLE TO REPRODUCE THE CUSTOMER ISSUE. THE
EVALUATION CONCLUDED THAT THE DEVICE WAS OPERATING AS DESIGNED. RESMED'S RISK
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Device Stops Intermittently;Device Displays Incorrect Message|IT WAS
REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE TRIGGERED AN ALARM AND RESTARTED.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR:#3004604967-
2015-00083.|
4649494||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|No
Display / Image|REF IMP:# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE EVALUATION
CONFIRMED THE TOUCH SCREEN FAILURE. THE DEVICE TOP CASE ASSEMBLY WAS REPLACED AND
THIS RESOLVED THE DISPLAY ISSUE. AFTER THE DEVICE WAS REPAIRED, SYSTEM ERROR
(SF148) INDICATING THE MAIN BLOWER IS OVERHEATING WAS OBSERVED. THE DEVICE IS
CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN
4649525||NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150- DEU|Malfunction|
Device Displays Incorrect Message|REF IMP#: (B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE
EVALUATION CONFIRMED THE REPORTED SELF-TEST FAILURE. THE DEVICE IS CURRENTLY BEING
4649527||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SGL KIT -FRA|Malfunction|
Device Displays Incorrect Message|REF IMP#: (B)(4).|THE DEVICE WAS EVALUATED BY A
RESMED DISTRIBUTOR IN THE (B)(4). THE EVALUATION DETERMINED THE ROOT CAUSE TO BE
THE PNEUMATIC BLOCK COMPONENT. THE COMPONENTS WAS REPLACED TO RESOLVE THE ISSUE.
(B)(4).
DEVICE'S TOUCH SCREEN BECAME INOPERABLE AFTER IT WAS PHYSICALLY DAMAGED AT THE
CUSTOMER'S SITE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR REF: #3004604967-2015-00084.|
4649536||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SGL KIT -FRA|Malfunction|
Material Frayed|(B)(4)|THE POWER CORD AND POWER SUPPLY WERE RETURNED TO RESMED
TECHNICAL SERVICE IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
CONFIRMED THAT POWER CORD WIRE WAS EXPOSED. THE POWER SUPPLY WAS REPLACED TO
ADDRESS THIS ISSUE. (B)(4).
4649537|20150201|NOU|Continuous, Ventilator, Home Use|27072|ASTRAL 100 SGL KIT-
FRA|Malfunction|Material Frayed|IT WAS REPORTED TO RESMED (B)(4) THAT THE POWER
CORD OF THE ASTRAL DEVICE HAD AN EXPOSED WIRE. THERE WAS NO REPORT OF DEVICE
MALFUNCTION OR PATIENT HARM. REF MFR#: 3004604967-2015-00085.|
THE ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR#: 3004604967-2015-00086.|
THAT A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A POSITIVE END
EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE. THIS RESULTED IN AN ALARM WHICH NOTIFIED
THE USER OF THE ERROR MESSAGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. REF MFR#: 3004604967-2015-00087.|
Adverse Event Without Identified Device or Use Problem|IMP REF#:(B)(4).|THE DEVICE
WAS RECEIVED BY RESMED, (B)(4). IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN SYDNEY, AUSTRALIA, FOR AN ENGINEERING INVESTIGATION. THE
INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE.
RESMED, (B)(4) IS WORKING WITH THE CUSTOMER TO GATHER MORE INFO ON THIS INCIDENT.
(B)(4). IT WAS REPORTED TO RESMED, (B)(4) THAT THE PT HAD TWO (2) ASTRAL DEVICES,
SERIAL NOS: (B)(4). RESMED IS WORKING WITH THE CUSTOMER TO DETERMINE WHICH DEVICE
WAS USED ON THE PT AT THE TIME OF THE REPORTED INCIDENT. REFERENCE MEDWATCH
3004604967-2015-00069 FOR ASTRAL DEVICE SERIAL NO: (B)(4).
Adverse Event Without Identified Device or Use Problem|(B)(4)|THE DEVICE WAS
RECEIVED BY RESMED, (B)(4). IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN (B)(4), FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED, (B)(4) IS
WORKING WITH THE CUSTOMER TO GATHER MORE INFO ON THIS INCIDENT. (B)(4). IT WAS
REPORTED TO RESMED, (B)(4) THAT THE PT HAD TWO (2) ASTRAL DEVICES, SERIAL NOS: (B)
(4). RESMED IS WORKING WITH THE CUSTOMER TO DETERMINE WHICH DEVICE WAS USED ON THE
PT AT THE TIME OF THE REPORTED INCIDENT. (B)(4).
Stops Intermittently|(B)(4)|THE DEVICE WAS RETURNED TO THE RESMED TECH SVS IN (B)
(4) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
Displays Incorrect Message|(B)(4)|RESMED HAS REQUESTED FOR THE DEVICE TO BE
Device Stops Intermittently|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECH SVS
IN (B)(6) AND IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REF #: (B)(4).
Appropriate Term/Code Not Available|(B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED REF #: (B)(4).
Inoperable|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECH SERVICE. EVAL CONFIRMED
THAT THE DEVICE SCREEN WAS FLICKERING. THE TOP CASE ASSEMBLY OF THE DEVICE WAS
REPLACED TO ADDRESS THE ISSUE. RESMED HAS INVESTIGATED SIMILAR COMPLAINTS AND NO
DEVICES WITH FLICKERING SCREENS HAVE BEEN CONFIRMED AS BECOMING INOPERABLE. RESMED
REF #: (B)(4).
4653563||NOU|Continuous, Ventilator, Home Use||ASTRAL 150- AMER|Malfunction|Device
REF #: (B)(4).
REF #: (B)(4).
REF #: (B)(4).
REF #: (B)(4).
Failure to Charge|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED TECH SERVICE FOR AN
EVAL. THE EVAL CONFIRMED THE CUSTOMER REPORT OF BATTERY NOT CHARGING. THE BATTERY
WAS REPLACED TO ADDRESS THE ISSUE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REF #: (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECH SVS
IN (B)(4) AND A PRELIMINARY EVAL WAS PERFORMED. THE EVAL SHOWED THAT A SYSTEM FAULT
OCCURRED ON AN ASTRAL DEVICE INDICATING A FAULT. THE DEVICE WAS RETURNED TO THE
RESMED REF #: (B)(4).
Death|Adverse Event Without Identified Device or Use Problem|IT WAS REPORTED TO
RESMED (B)(4) THAT A PT DIED IN THE HOSP WHILE USING AN ASTRAL DEVICE. NO DEVICE
MALFUNCTION WAS REPORTED BY THE CUSTOMER REQUEST THE DEVICE BE EVALUATED. MFR REF
#: 3004604967-2015-00070.|
Malfunction|Device Stops Intermittently|IT WAS REPORTED BY RESMED (B)(4) THAT AN
ASTRAL DEVICE RESTARTED UNEXPECTEDLY AT THE DISTRIBUTOR'S FACILITY. THE DEVICE WAS
NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. MFR REF
#: 3004604967-2015-00071.|
4653639|20150201|NOU|Continuous, Ventilator, Home Use|27023|ASTRAL 150 - EUR 2|
THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. PER
THE REPORTER, THE DOCTOR WAS WITH THE PT AT THE TIME OF THE INCIDENT AND MANUALLY
VENTILATED THE PT WHILE THE DEVICE WAS RESTARTED. THE DOCTOR CONTINUED TO USE THE
DEVICE AFTER THE REPORTED EVENT. THERE WAS NO PT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR REF#:3004604967-2015-00072.|
Malfunction|Appropriate Term/Code Not Available|IT WAS REPORTED TO RESMED THAT AN
ASTRAL 150 DEVICE WAS NOT ALLOWING THE CLINICIAN TO PROGRAM THE DEVICE FOR DOUBLE
LIMB CIRCUIT. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PT INVOLVEMENT. MFR REF #: 3004604967-2015-00075.|
RESMED FRANCE THAT A PT DIED IN THE HOSP WHILE USING AN ASTRAL DEVICE. NO DEVICE
MALFUNCTION WAS REPORTED BUT THE CUSTOMER REQUEST THE DEVICE BE EVALUATED. MFR REF
#: 3004604967-2015-00069.|
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT THE
ASTRAL DEVICE STOPPED VENTILATION. THE CAREGIVER PLACED THE PT ON A BACK-UP DEVICE.
THE PT WAS REPORTED TO BE DOING FINE. THERE WAS NO PT INJURY REPORTED AS A RESULT
OF THIS INCIDENT. MFR REF #: 3004604967-2015-00074.|
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S
TOUCH SCREEN WAS FLICKERING AND THE DEVICE WAS INOPERABLE. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. MFR REF #:
3004604967-2015-00076.|
3004604967-2015-00077.|
3004604967-2015-00078.|
3004604967-2015-00080.|
Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S
BATTERY WAS NOT RECHARGING. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF
THIS INCIDENT. MFR REF #: 3004604967-2015-00081.|
AN ASTRAL DEVICE DISPLAYED A SYSTEM MESSAGE INDICATING A SOFTWARE TASK ERROR. THIS
RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS
NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR REF #: 3004604967-2015-
00082.|
Failure to Charge|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED TECHNICAL SERVICE FOR
AN EVALUATION. THE EVALUATION WAS NOT ABLE TO REPRODUCE THE CUSTOMER ISSUE; THE
RESULT IS "NO FAULT FOUND." (B)(4).
Device Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE DEVICE IS
CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN
Displays Incorrect Message|REFERENCE # (B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICES IN (B)(4). REVIEW OF THE DOWNLOADED DEVICE LOG CONFIRMED
THE CUSTOMER REPORTED ISSUE. THE DOWNLOADED DEVICE LOG AND DETAILED DATA ARE
CURRENTLY BEING EVALUATED BY THE DESIGN FACILITY. THE INVESTIGATION AND CONCLUSION
IS NOT FINALIZED AT THIS STAGE. (B)(4).
Stops Intermittently|(B)(4).|THE DEVICE WAS EVALUATED BY A RESMED (B)(4) TECHNICAL
SERVICE'S TECHNICIAN AT THE PATIENT SITE. THE DEVICE RESTART OCCURRED AFTER AN
OVERPRESSURE WAS DETECTED BY THE DEVICE. THE ISSUE WAS RESOLVED BY REPLACING THE
MAIN CIRCUIT BOARD (PCB) ON THE ASTRAL DEVICE. THE PCB IS CURRENTLY BEING RETURNED
TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING
AT THIS STAGE. (B)(4) .
Displays Incorrect Message|(B)(4) .|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN BREMEN GERMANY. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE
Battery Problem|(B)(4) .|THE DEVICE WAS RECEIVED BY RESMED FRANCE TECHNICAL SERVICE
FOR EVALUATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT
FINALIZED AT THIS STAGE. (B)(4).
4667500||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|Power
Problem|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE
EVALUATION CONFIRMED THE REPORTED POWER DETECTION ISSUE. THE DEVICE IS CURRENTLY
BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE ASTRAL DEVICE
IS NOT DETECTING THE CORRECT POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED AS
Battery Problem|(B)(4) .|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING
AT THIS STAGE. (B)(4) .
RECEIVED BY RESMED (B)(4) TECHNICAL SERVICE. THE DEVICE IS CURRENTLY BEING RETURNED
TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING
A SYSTEM FAULT MESSAGE WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET
CAREGIVER OF THE ERROR MESSAGES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00090.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE WHICH RESULTED IN AN ALARM NOTIFYING
THE USER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00093.|
DEVICE'S BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS
Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL INTERNAL
BATTERY WON'T HOLD A CHARGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED GERMANY THAT AN
ASTRAL DEVICE RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(6)
THAT A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE WHICH RESULTED IN AN ALARM
NOTIFYING THE USER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A
DEVICE'S BATTERY ALARM WAS TRIGGERED. THERE WAS NO PATIENT HARM OR INJURY REPORTED
AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00095.|
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING A FLOW SENSOR ISSUE. THIS
NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR #
3004604967-2015-00098.|
Device Stops Intermittently|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN BREMEN, (B)(4). THE DEVICE IS CURRENTLY BEING RETURNED TO THE MFG
Display / Image|PLEASE REFER IMPORTER REPORT #: (B)(4).|RESMED HAS REQUESTED FOR
TOUCH SCREEN TURNED RED AND VENTILATION STOPPED. THERE WAS NO PT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED GERMANY THAT AN
ASTRAL DEVICE RESTARTED UNEXPECTEDLY. THERE WAS NO PT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|
Failure to Calibrate|PLEASE REFER IMPORTER REPORT #: (B)(4).|AN EXTENSIVE
ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN
HOUSE IN SYDNEY, AUSTRALIA. THE INVESTIGATION DETERMINED THAT THE RETURNED DEVICE
HAD A LEAKY NRV VALVE. THIS CAUSED DEVICE FROM COMPLETING ITS INTERNAL SELF-TEST IN
ANY VALVE CONFIGURATION. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Failure to Calibrate|AN ASTRAL DEVICE WAS RETURNED TO RESMED FOR
FAILING TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT HARM OR INJURY REPORTED AS
A RESULT OF THIS INCIDENT. ADDITIONAL INFO FROM THE DEVICE INVESTIGATION COMPLETED
ON (B)(6) 2015 DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO FAIL ITS
INTERNAL SELF-TEST.|
4688218||NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50|Malfunction|
Device Displays Incorrect Message;No Flow;No Pressure|CUSTOMER DESCRIBES THAT THE
DEVICE HAS INDICATED AN INTERNAL FAULT, WITH ERROR CODE #39 ON THE DISPLAY. BASED
ON THE INFORMATION RECEIVED, THE POTENTIAL RISK ASSOCIATED WITH THE REPORTED EVENT
IS CLASSIFIED AS CRITICAL SINCE THE REPORTED FAULT MAY INTENTIONALLY TERMINATE
TREATMENT, AS A RISK MITIGATION, WITH A HIGH PRIORITY ALARM. BASED ON THE
INFORMATION PROVIDED AT THIS TIME, INCLUDING UNKNOWN PATIENT OUTCOME, THE EVENT IS
CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|RETURN OF DEFECTIVE MATERIAL TO
MANUFACTURER FOR REPAIR HAS BEEN AUTHORIZED ((B)(4)) BUT DEVICE HAS NOT YET BEEN
RECEIVED.
Battery Problem;Device Displays Incorrect Message|(B)(4).|RESMED HAS REQUESTED FOR
THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE
ALLEGED MALFUNCTION AT THIS TIME. (B)(4) .
No Display / Image|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECH SVS IN
FRANCE. THE DEVICE TOP CASE ASSEMBLY WAS REPLACED AND THIS RESOLVED THE DISPLAY
ISSUE. (B)(4) .
Displays Incorrect Message|(B)(4) .|THE DEVICE WAS EVALUATED BY RESMED (B)(4)
TECHNICAL SVC. THE INVESTIGATION DETERMINED THAT SYSTEM FAULTS (SF) 101 AND 218
WERE TRIGGERED WHEN THE USER DISCONNECTED THE PRESSURE LINE FROM THE DEVICE. THE
INVESTIGATION CONCLUDED THAT THE DEVICE WAS OPERATING AS DESIGNED. (B)(4) .
FACILITY LOCATED IN (B)(4), FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).
Communication or Transmission Problem|(B)(6) .|THE DEVICE WAS RETURNED TO THE
RESMED TECH SVS IN BREMEN, GERMANY. THE DEVICE IS CURRENTLY BEING RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN SYDNEY, AUSTRALIA FOR AN ENGINEERING
INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4) .
Malfunction|Communication or Transmission Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT A SYSTEM FAULT (SF180) WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A LOSS OF
COMMUNICATION. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
MESSAGE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #:
3004604967-2015-00105.|
Device Stops Intermittently|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECH SVS
IN (B)(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED AND AN
EVAL WAS PERFORMED. THE EVAL CONFIRMED THAT THE CIRCUIT FAULT ALARM WAS TRIGGERED.
THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) , FOR AN
ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE
NOT FINALIZED AT THIS STAGE. (B)(4) .
Malfunction|Battery Problem;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED THAT A SYSTEM FAULT (SF180) OCCURRED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF
THE ERROR MESSAGE. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #: 3004604967-2015-00100.|
DEVICE'S TOUCH SCREEN WAS SCRAMBLING AND ALL BLACK. THERE WAS NO PT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR #: 3004604967-2015-00101.|
CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #: 3004604967-2015-00102.|
Malfunction|Device Displays Incorrect Message|AN ASTRAL DEVICE WAS RETURNED TO
RESMED FOR EVAL. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT A SYSTEM FAULT
MESSAGE (SF74) INDICATING A SOFTWARE TASK ERROR HAS OCCURRED. THIS RESULTED IN AN
ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PT HARM OR
INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00103.|
A SYSTEM FAULT (SF101) WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET
THIS INCIDENT. MFR #: 3004604967-2015-00104.|
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT THE
ASTRAL DEVICE RESTARTED. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #: 3004604967-2015-00106.|
4695078|20150301|NOU|Continuous, Ventilator, Home Use|27003|ASRAL 150 - AMER|
ASTRAL DEVICE TRIGGERED AN AUDIBLE ALARM WITH ERROR MESSAGE INDICATING AN INCORRECT
PT CIRCUIT. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR #: 3004604967-2015-00107.|
RESMED FRANCE THAT A PT USING AN ASTRAL DEVICE PASSED AWAY. MFR # 3004604967-2015-
00108.|
4712865||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DBL KIT FRA|Death|Adverse
Event Without Identified Device or Use Problem|(B)(6) .|THE DEVICE WAS RECEIVED BY
RESMED FRANC. A PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE SHOWED THAT THE
DEVICE OPERATED NORMALLY. THERE WAS NO INDICATION THAT THE DEVICE MALFUNCTIONED. AN
ENGINEERING INVESTIGATION IS CURRENTLY IN PROGRESS. THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4) .
Device Stops Intermittently;Device Displays Incorrect Message|(B)(4) .|THE DEVICE
WAS RECEIVED BY RESMED (B)(4) AND THE DEVICE WAS RETURNED TO THE MFG FACILITY
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4) .
Displays Incorrect Message|(B)(4) .|THE CUSTOMER INFORMED RESMED TECHNICAL SUPPORT
REGARDING A DEVICE CIRCUIT FAULT IN THE ASTRAL DEVICE. NO DEVICE WAS RETURNED TO
RESMED FOR INVESTIGATION. THE PT DEVICE WAS SWITCHED TO A SINGLE VALVE CIRCUIT
WHICH RESOLVED THE ISSUE. (B)(4) .
4719901||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|Malfunction|
Communication or Transmission Problem|(B)(4) .|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL WAS NOT
ABLE TO REPRODUCE THE CUSTOMER ISSUE. THE EVAL CONCLUDED THAT THE DEVICE WAS
OPERATING AS DESIGNED. (B)(4) .
Power Problem|(B)(4) .|THE PSU WAS EVALUATED BY RESMED (B)(4) TECHNICAL SERVICE AND
IT WAS FOUND THAT THE PSU WAS NOT WORKING. THE PSU WAS REPLACED TO ADDRESS THIS
ISSUE. (B)(4) .
4719914||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|
Communication or Transmission Problem|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL CONCLUDED
THAT THE DEVICE WAS OPERATING AS DESIGNED. (B)(4).
4719918||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - FRA|Malfunction|Device
Displays Incorrect Message;Battery Problem|(B)(4).|PER THE REPORTER, THE BATTERY
ALARM HAS NOT RECURRED. THE DEVICE WAS NOT RETURNED TO RESMED FOR INVESTIGATION.
(B)(4) .
Displays Incorrect Message|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND AN INVESTIGATION WAS PERFORMED. THE INVESTIGATION
WAS NOT ABLE TO REPRODUCE THE CUSTOMER ISSUE ON THE RETURNED DEVICE. THE
INVESTIGATION CONCLUDED THAT THE DEVICE WAS OPERATING AS DESIGNED. (B)(4).
Displays Incorrect Message|IMP # (B)(4).|THE ASTRAL DEVICE WAS RETURNED TO THE
RESMED AND AN INVESTIGATION WAS PERFORMED. REVIEW OF THE DOWNLOADED THERAPY DATA
SHOWED THAT A SYSTEM FAULT 180, INDICATING A BATTERY CHARGER FAULT, TRIGGERED. THE
REPORT OF POWER FAILURE WAS NOT CONFIRMED. THIS TYPE OF ALARM WILL NOT AFFECT THE
PT SHOULD IT OCCUR DURING VENTILATION. RESMED RISK ANALYSIS FOR THIS FAILURE MODE
Malfunction|Device Displays Incorrect Message;Device Stops Intermittently|IT WAS
REPORTED TO RESMED (B)(4) THAT AN SYSTEM FAULT (SF101) MESSAGE WAS OBSERVED ON AN
ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT.
THIS RESULTED IN AN ALARM, THE DEVICE SCREEN TURNED RED, AND VENTILATION STOPPED.
THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604976-
2015-00109.|
Malfunction|Communication or Transmission Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT AN SYSTEM FAULT (SF101) MESSAGE WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A
LOSS OF COMMUNICATION. THIS RESULTED IN AN ALARM THAT NOTIFIED THE CAREGIVER OF THE
ERROR MESSAGE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #
3004604967-2015-00111.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS NOT FUNCTIONING. THE DEVICE WAS NOT IN USE
WHEN THE FAULT; THEREFORE, THERE WAS NO PT INVOLVEMENT. MFR # 3004604967-2015-
00112.|
ASTRAL DEVICE TRIGGERED AN AUDIBLE ALARM WITH ERROR MESSAGE INDICATING A DEVICE
CIRCUIT FAULT. THERE WAS NO PT INJURY OR HARM REPORTED AS A RESULT OF THIS
INCIDENT. MFR # 3004604967-2015-00110.|
Malfunction|Communication or Transmission Problem|IT WAS REPORTED TO RESMED GERMANY
THAT A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE WHICH RESULTED IN AN ALARM
NOTIFYING THE USER OF THE ERROR MESSAGE. THERE WAS NO PT INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00113.|
4720012|20150301|NOU|Continuous, Ventilator, Home Use|27073|ASTRAL 150 - FRA|
Malfunction|Device Displays Incorrect Message;Battery Problem|IT WAS REPORTED TO
RESMED (B)(4) THAT THE ASTRAL DEVICE'S INTERNAL BATTERY WAS INOPERABLE. THIS
RESULTED IN AN ALARM, WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THE DEVICE
WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PT INVOLVEMENT.
MFR# 300404967-2015-00114.|
PRESSURE MEASUREMENT MAY BE INCORRECT. THIS RESULTED IN AN ALARM THAT NOTIFIED THE
ASTRAL DEVICE HAD A POWER FAILURE. THERE WAS NO PT HARM OR INJURY REPORTED AS A
ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. REFERENCE MFR
# 3004604967-2015-00117.|
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN
(B)(4). ADDITIONAL INFORMATION FROM THE DEVICE INVESTIGATION COMPLETED ON (B)(6)
2015 DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO FAIL ITS INTERNAL
SELF-TEST. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE WAS A
SOFTWARE FAULT. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. (B)(4).
EUR4|Malfunction|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED (B)
(4) THAT AN ASTRAL DEVICE'S TOUCH SCREEN WAS STUCK ON THE RESMED LOGO AND THEN IT
TURNED BLACK. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR # 3004604967-2015-00118.|
A SYSTEM FAULT OCCURRED IN AN ASTRAL VENTILATOR WHICH INDICATED THAT THE DEVICE WAS
OUT OF CALIBRATION. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF
Malfunction|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE'S DISPLAY SCREEN WAS FLASHING AND THE DEVICE WAS INOPERABLE. THERE
WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #
3004604967-2015-00124.|
Malfunction|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE'S DISPLAY SCREEN WAS BLANK AND THE DEVICE WAS INOPERABLE.
THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #
3004604967-2015-00125.|
Displays Incorrect Message|(B)(4).|AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN SYDNEY, AUSTRALIA.
ADDITIONAL INFORMATION FROM THE DEVICE INVESTIGATION COMPLETED ON MARCH 22, 2015
DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE WAS A SOFTWARE FAULT RESMED'S RISK
Displays Incorrect Message|IMP # (B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE
4736037||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - FUKUDA|Malfunction|
Device Inoperable;No Display / Image|IMP # (B)(4).|RESMED HAS REQUESTED FOR THE
DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE
DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED
AN ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST DURING INCOMING
INSPECTION. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT. MFR # 3004604967-2015-00119.|
Malfunction|Pressure Problem|AN ASTRAL DEVICE WAS RETURNED TO RESMED (B)(4) FOR
GENERAL SERVICE AND EVALUATION. DURING EVALUATION, IT WAS FOUND THAT DEVICE FAILED
THE FINAL ASSEMBLY LEAK TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MFR # 3004604967-2015-00121.|
SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE INDICATING A SOFTWARE FAULT. THIS
NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604967-
2015-00122.|
4736051|20150301|NOU|Continuous, Ventilator, Home Use|27093|ASTRAL 150 - FUKUDA|
Malfunction|No Display / Image;Device Inoperable|IT WAS REPORTED TO RESMED (B)(4)
THAT ASTRAL DEVICE'S TOUCH SCREEN FAILED AND VENTILATION STOPPED. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT O THIS INCIDENT. (B)(4).|
4736067||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SGL KIT - EUR4|
Malfunction|No Display / Image;Device Inoperable|IMP # (B)(4).|THE DEVICE WAS
RETURNED TO THE RESMED TECHNICAL SERVICES IN THE (B)(4). THE INVESTIGATION METHODS,
Displays Incorrect Message|IMP # (B)(4).|THE DEVICE WAS RETURNED TO RESMED
TECHNICAL SERVICES IN (B)(4) FOR INVESTIGATION. THE INVESTIGATION METHODS, RESULTS,
AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Pressure Problem|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING
Display / Image;Device Inoperable|IMP # (B)(4).|THE DEVICE WAS EVALUATED BY RESMED
TECHNICAL SERVICE. THE EVALUATION CONFIRMED THAT THE DEVICE DISPLAY SCREEN WAS
FLASHING. THE TOP CASE ASSEMBLY OF THE DEVICE WAS REPLACED TO ADDRESS THE ISSUE.
(B)(4).
4736081||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC|Malfunction|No
Display / Image;Device Inoperable|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATED. THE
INVESTIGATION METHODS, RESULTS, AND CONCLUSION AR NOT FINALIZED AT THIS STAGE. (B)
(4).
Displays Incorrect Message|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
CONCLUDED THAT THE DEVICE WAS OPERATING AS DESIGNED. RESMED'S RISK ANALYSIS FOR
Displays Incorrect Message;No Display / Image|IMP # (B)(4).|PER THE REPORTER, THE
PATIENT'S FATHER REPORTED THE ISSUE WAS DUE TO THE DISCONNECTED OR LOOSE DEVICE
CIRCUIT. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. (B)(4).
Malfunction|Device Displays Incorrect Message;No Display / Image|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAY DISPLAYED AN ALARM (SF101) INDICATING THAT THE
OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00126.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE WHICH RESULTED IN AN ALARM NOTIFYING
THE USER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
Displays Incorrect Message|IMP # (B)(4).|THE DEVICE WAS RECEIVED BY RESMED CORP AND
IT IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN SYNDEY
ASTRAL VENTILATOR FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM
OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00129.|
Malfunction|Device Inoperable;Power Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE HAD A FAULTY POWER BUTTON. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. REF MFR# 3004604967-2015-000128.|
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. REF MFR#: 3004604967-2015-00132.|
4751927||NOU|Continuous, Ventilator, Home Use||BLOC PNEUMATIQUE - ASTRAL|
Malfunction|Device Sensing Problem|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)
(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS
STAGE. (B)(4).
4751940|20150401|NOU|Continuous, Ventilator, Home Use|19623|BLOC PNEUMATIQUE -
ASTRAL|Malfunction|Device Sensing Problem|IT WAS REPORTED BY RESMED (B)(4) THAT THE
CIRCUIT IDENTIFICATION OF THE ASTRAL DEVICE WAS NOT RECOGNIZED. THIS RESULTED IN
THE DEVICE NOT VENTILATING. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PT INVOLVEMENT. REF MFR# 3004604967-2013-00131.|
ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THIS RESULTED IN AN ALARM
NOTIFYING THE USER OF THE ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. REF MFR # 3004604967-2015-00130.|
4751950||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - FRA|Malfunction|Device
Inoperable;Power Problem|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED
SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET
BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT
THIS TIME. (B)(4).
Failure to Calibrate|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECHNICAL SERVICE.
THE EVALUATION CONFIRMED THAT THE DEVICE FAILED ITS INTERNAL SELF-TEST. REVIEW OF
THE DOWNLOADED DEVICE LOG SHOWED THAT A SYSTEM FAULT (SF74) MESSAGE INDICATING A
SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
Device Operates Differently Than Expected|A REPORT WAS RECEIVED STATING THE
SILENCE/RESET LIGHT EMITTING DIODE (LED) BUTTON OF A VENTILATOR WAS BLINKING DURING
PATIENT USE. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE
VENTILATOR WITHOUT HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED
WITH THIS EVENT.|(B)(4). IT WAS REPORTED BY THE DISTRIBUTOR THAT THE REPORTED EVENT
WAS NOT DUPLICATED.
Malfunction|Device Displays Incorrect Message;Device Inoperable|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE AND WAS INOPERABLE. THERE
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR #
3004604967-2015-00134.|
Inoperable;Device Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE
DEVICE WAS EVALUATED BY RESMED TECHNICAL SERVICE. A REVIEW OF THE DOWNLOADED DEVICE
LOG SHOWED THAT THE DEVICE HAD AN INTERNAL SELF-TEST FAILURE. THE DEVICE WAS
Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECHNICAL
SERVICE. A REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT AN INCORRECT CIRCUIT
ALARM WAS TRIGGERED IN THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN SYDNEY AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE
(4).
ASTRAL DEVICE TRIGGERED AN INCORRECT CIRCUIT ALARM. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR-3004604967-2015-00139.|
Malfunction|Failure to Calibrate|IT WAS NOT REPORTED TO RESMED FRANCE THAT AN
ASTRAL DEVICE WILL NOT CALIBRATE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00136.|
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. ADDITIONAL INFORMATION FROM THE DEVICE INVESTIGATION
COMPLETED ON APRIL 2015 DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO
FAIL ITS INTERNAL SELF-TEST. REFERENCE MFR # 3004604967-205-00138.|
Malfunction|No Display / Image;Device Displays Incorrect Message;Device Inoperable|
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE TOUCHSCREEN DISPLAY WILL NOT TURN
ON. THIS RESULTED IN AN ALARM NOTIFYING THE USER OF THE ERROR MESSAGE. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-
2015-00140.|
Failure to Calibrate|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(6) . AN
ENGINEERING INVESTIGATION IS CURRENTLY IN PROGRESS. THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4) .
Failure to Calibrate|(B)(4).|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED
ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). THE INVESTIGATION
DETERMINED THAT THE RETURNED DEVICE HAD A LEAKY NON-RETURN VALVE (NRV). THIS CAUSED
DEVICE TO NOT PASS ITS INTERNAL SELF-TEST IN ANY CIRCUIT CONFIGURATION. RESMED'S
RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)
(4).
Display / Image;Device Displays Incorrect Message;Device Inoperable|(B)(4).|THE
DEVICE WAS EVALUATED BY RESMED TECHNICAL SERVICE. THE EVALUATION CONFIRMED THAT THE
DEVICE'S DISPLAY SCREEN WAS BLANK AND AN ALARM WAS TRIGGERED. THE DEVICE WAS
SYSTEM FAULT 74 MESSAGE WAS DISPLAYED IN AN ASTRAL DEVICE INDICATING A SOFTWARE
TASK ERROR. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PT INVOLVEMENT. REF MFR # 3004604967-2015-00142.|
Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL
DEVICE'S HIGH PRESSURE ALARM WAS TRIGGERED. THERE WAS NO PT INJURY REPORTED AS A
RESULT OF THIS INCIDENT. REF MFR# 3004604967-2015-00143.|
DEVICE'S ALARM LIGHT WAS POORLY ILLUMINATING (DIM). THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. REF MFR# 3004604967-2015-00144.|
Malfunction|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE'S DISPLAY SCREEN WAS FLICKERING/SCROLLING AND THE DEVICE WAS
INOPERABLE. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR # 3004604967-2015-00141.|
AN ASTRAL DEVICE DISPLAYED AN ERROR CODE 74 MESSAGE INDICATING A SOFTWARE TASK
ERROR. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE.
THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. REF MFR# 3004604967-
2015-00145.|
Pressure Problem|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4). AN ENGINEERING
INVESTIGATION IS CURRENTLY IN PROGRESS. THE INVESTIGATION METHODS, RESULTS, AND
Display / Image;Device Inoperable|(B)(4).|THE RETURNED DEVICE WAS EVALUATED BY
RESMED TECHNICAL SERVICE. THE EVALUATION WAS UNABLE TO DUPLICATE THE DEVICE DISPLAY
SCREEN FLICKERING, HOWEVER, A SOFTWARE TASK ERROR AS WELL AS A BATTERY CHARGER
FAULT WAS FOUND INT HE DOWNLOADED ERROR LOGS. THE DEVICE WAS REPAIRED TO ADDRESS
THESE ISSUES. (B)(4).
Displays Incorrect Message|(B)(4).|PER THE REPORTER, THE NURSE OBSERVED THE SYSTEM
FAULT OCCURRENCE IN THE DEVICES DOWNLOADED ERROR LOG. THE DEVICE WAS REBOOTED AND
THE ERROR SELF-CLEARED. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. (B)(4).
Alarm System|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED TECHNICAL SERVICES IN (B)(6)
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THE ALARM (BOTH AUDIBLE
AND VISUAL) WAS STILL FUNCTIONING PROPERLY BUT WAS NOT ILLUMINATING AT THE DESIRED
BRIGHTNESS. THE TOP CAUSE ASSEMBLY OF THE DEVICE WAS REPLACED TO ADDRESS THE ISSUE.
(B)(4).
SERVICE IN (B)(6) AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED
ERROR LOGS CONFIRMED THAT A SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE. ALL
INVESTIGATION ATTEMPTS TO REPLICATED THE FAULT AS WELL AS A VISUAL INSPECTION
DETERMINED THE DEVICE IS OPERATING WITHOUT FAULT. RESMED RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PT INJURY REPORTED
FOR THIS INCIDENT. (B)(4).
Device Displays Incorrect Message|IMP- (B)(4).|THE DEVICE WAS RECEIVED BY RESMED
(B)(4). THE PRELIMINARY EVALUATION IDENTIFIED THE ROOT CAUSE OF THE SYSTEM FAULT AS
WATER INGRESS INSIDE THE UNIT. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Displays Incorrect Message|IMP-(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(6) AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE
DOWNLOADED ERROR LOGS CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74 WAS
TRIGGERED IN THE DEVICE. ALL INVESTIGATION ATTEMPTS TO REPLICATE THE FAULT AS WELL
AS A VISUAL INSPECTION DETERMINED THE DEVICE IS OPERATING WITHOUT FAULT. RESMED
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
4778765||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 - EUR4|Malfunction|
Battery Problem;Device Inoperable|IMP-(B)(4).|THE DEVICE WAS RECEIVED BY RESMED
TECHNICAL SERVICE IN (B)(4). AN ENGINEERING INVESTIGATION IS CURRENTLY IN PROGRESS.
(B)(4).
Malfunction|Battery Problem;Device Inoperable|IT WAS REPORTED TO RESMED (B)(6) THAT
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE "INTERNAL BATTERY INOPERABLE." THIS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR 3004604967-2015-
00147.|
AN SYSTEM FAULT MESSAGE WAS DISPLAYED ON A ASTRAL DEVICE INDICATING A OUTLET FLOW
SENSOR ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR 3004604967-2015-00148.|
AN SYSTEM FAULT 74 MESSAGE WAS DISPLAYED IN AN ASTRAL DEVICE INDICATING A SOFTWARE
TASK ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
3004604967-2015-00150.|
4785528||NOU|Continuous, Ventilator, Home Use||PSU - ASTRAL|Malfunction|Power
Problem|IMP REF#: (B)(4).|THE POWER SUPPLY WAS NOT RETURNED TO THE MFR FOR AN
INVESTIGATION. PER THE REPORTER, THE PSU WAS DISCARDED BY THE DISTRIBUTOR. RESMED
PROVIDED THE DISTRIBUTOR WITH A REPLACEMENT PSU TO ADDRESS THIS ISSUE. (B)(4).
Failure to Calibrate|IMP REF#: (B)(4).|AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN SYDNEY, AUSTRALIA.
THE INVESTIGATION DETERMINED THAT THE RETURNED DEVICE HAD A FAULTY NON-RETURN VALVE
(NRV). THIS CAUSED THE DEVICE FROM COMPLETING ITS INTERNAL SELF-TEST IN ANY VALVE
CONFIGURATION. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
Pressure Problem|IMP REF#: (B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4). THE
DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4)
Failure to Cycle|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECH SERVICES AND AN
EVALUATION WAS PERFORMED. THE EVALUATION CONCLUDED THAT THE DEVICE WAS OPERATING AS
DESIGNED. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. RESMED PREFERENCE#: (B)(4).
Failure to Calibrate|IMP REF #: (B)(4).|THE DEVICE WAS EVALUATED BY RESMED
TECHNICAL SERVICE. THE EVALUATION CONFIRMED THAT THE DEVICE FAILED ITS INTERNAL
SELF-TEST. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY
Device Displays Incorrect Message|IMP REF#: (B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4). THE PRELIMINARY EVALUATION CONFIRMED THAT A SYSTEM FAULT 75 WAS
TRIGGERED ON THE DEVICE. AN ENGINEERING INVESTIGATION IS CURRENTLY IN PROGRESS AT
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4). THE INVESTIGATION METHODS, RESULTS
AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS
4785557|20150401|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|
Malfunction|Failure to Calibrate|IMP REF#: (B)(4).|AN EVALUATION WAS PERFORMED BY
RESMED TECH SERVICE. THE INTERNAL INSPECTION REVEALED A FAULTY PNEUMATIC BLOCK. (B)
(4).
4785559||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - FRA|Malfunction|Failure
to Calibrate|(B)(4).|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE
RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(6). THE INVESTIGATION DETERMINED
THAT THE RETURNED DEVICE HAD A FAULTY NON-RETURN VALVE (NRV). THIS CAUSED THE
DEVICE FROM COMPLETING ITS INTERNAL SELF-TEST IN ANY VALVE CONFIGURATION. RESMED'S
RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDED THAT THE RISK IS ACCEPTABLE. RESMED
REF#: (B)(4).
Failure to Calibrate|IMP#: (B)(4).|AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). THE
INVESTIGATION DETERMINED THE FAILURE WAS DUE TO AN ISOLATED COMPONENT FAILURE ON
THE MAIN PCB. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
Failure to Calibrate|IMP REF#: (B)(4).|THE DEVICE WAS RECEIVED BY RESMED FRANCE.
THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN
4785613|20150414|NOU|Continuous, Ventilator, Home Use|27003|ASTRAL 150 -AMER|
Malfunction|Failure to Cycle|IT WAS REPORTED TO RESMED THAT THE CLINICIAN WAS
VENTILATOR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
REF #: 3004604967-2015-00149.|
FAILED TO PASS ITS INTERNAL SELF-TEST. THIS RESULTED IN A WARNING ALARM NOTIFYING
THE USER OF THE ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MFR REF #: 3004604967-2015-00151.|
A SYSTEM FAULT 75 MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING THE
PNEUMATIC BLOCK SOFTWARE IS NOT CALIBRATING. THERE WAS NO PATIENT INJURY REPORTS AS
A RESULT OF THIS INCIDENT. MFR REF#: 3004604967-2015-00153.|
4785616|20150401|NOU|Continuous, Ventilator, Home Use|27943|PSU - ASTRAL|
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS NOT FUNCTIONING. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR REF#: 3004604967-2015-00154.|
AS A RESULT OF THIS INCIDENT. MFR REF#: 3004604967-2015-00157.|
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MFR REF#: 3004604967-
2015-00158.|
4785636|20150401|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DDBL KIT
FRA|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MFR REF#:
3004604967-2015-159.|
ROUTINE SERVICING. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING THE
EVALUATION OF THE DEVICE AT THE RESMED SERVICE CENTER THE DEVICE FAILED TO PASS ITS
INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT. MFR REF#: 3004604967-2015-00155.|
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED FRANCE THAT AN ASTRAL
AS A RESULT OF THIS INCIDENT. MFR REF#: 3004604967-2015-00156.|
Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE
WAS HAVING PRESSURE PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. MFR REF#: 3004604967-2015-00160.|
Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4).
THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
(6).FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR.#: 3004604967-2015-00152.|
Malfunction|Loss of Power|IT WAS REPORTED TO RESMED FRANCE THAT AN ASTRAL DEVICE
HAD A POWER FAILURE AND AN ALARM WAS TRIGGERED WHICH NOTIFIED THE CAREGIVER OF THE
MALFUNCTION. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
FAILED TO PASS ITS INTERNAL SELF-TEST. THIS RESULTED IN A WARNING ALARM NOTIFYING
THE USER OF THE ERROR MESSAGE. THE DEVICE WAS NOT IN USE THEREFORE, THERE WAS NO PT
INVOLVEMENT.|
Loss of Power|PLEASE REFER TO IMPORTER REPORT #: (B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4). THE DEVICE WAS RETURNED TO THE MFG FACILITY LOCATED IN (B)(4) FOR AN
Failure to Calibrate|PLEASE REFER TO IMPORTER REPORT #: (B)(4).|THE DEVICE WAS
EVALUATED BY RESMED TECHNICAL SERVICE. THE EVALUATION CONFIRMED THAT THE DEVICE
FAILED IT INTERNAL SELF-TEST. INSPECTION FOUND THE NON-RETURN VALVE (NRV) WAS
FAULTY. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. (B)(4).
4799413||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DBL KIT - EUR4|
Malfunction|Device Displays Incorrect Message|PLEASE SEE IMPORTER REPORT #: (B)
(4).|AN INVESTIGATION IS CURRENTLY IN PROGRESS AT THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT
Power Problem|PLEASE SEE IMPORTER REPORT #: (B)(4).|THE DEVICE WAS RECEIVED BY
RESMED (B)(4). THE DEVICE WAS RETURNED TO THE MFG FACILITY LOCATED IN (B)(4) FOR AN
EUR4|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED (B)(6)
THAT DURING SERVICE MAINTENANCE, AN ASTRAL DEVICE FAILED TO PASS THE DEVICE SERVICE
INVOLVEMENT.|
Malfunction|Power Problem|IT WAS REPORTED BY RESMED (B)(4) THAT A SYSTEM FAULT
(SF180) OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER FAULT. THE
RESULTED IN AN ALARM WHICH NOTIFIED THE USER OF THE ERROR MESSAGE. THERE WAS NO PT
No Display / Image;Device Inoperable|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED
FRANCE. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR
AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. (B)(4).
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED
Sensing Problem|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT
RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS
TIME. (B)(4).
No answer provided|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL DEVICE'S DISPLAY SCREEN TURNED RED AND THE CLINICIAN WAS
UNABLE TO ACCESS THE DEVICE SETTINGS. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE
CAREGIVER OF THE MALFUNCTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. PLEASE REFERENCE MFR#: 3004604967-2015-00167.|
Malfunction|Device Sensing Problem|IT WAS REPORTED TO RESMED THAT THE CLINICIAN WAS
VENTILATOR. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT. PLEASE REFERENCE MFR#: 3004604967-2015-00166.|
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT DURING A
SERVICE EVALUATION AT THE DISTRIBUTOR SITE, AN ASTRAL DEVICE FAILED TO PASS ITS
INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT. PLEASE REFERENCE MFR#: 3004604967-2015-00168.|
Malfunction|Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS SENT TO THE
RESMED SERVICE CENTER IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
4809047|20150401|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - EUR4|
Problem;Failure to Power Up|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
MFG FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE#
(B)(4).
4809069|20150430|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|
Malfunction|Device Sensing Problem|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED
TECHNICAL SERVICE. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT A SYSTEM FAULT
(SF74) MESSAGE INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS SENT TO
THE MFG FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
EUR4|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED ITALY
THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74, MESSAGE INDICATING A SOFTWARE
TASK ERROR. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
MESSAGE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR REF #
3004604967-2015-00171.|
VENTILATOR. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PT INVOLVEMENT. MFR REF # 3004604967-2015-00174.|
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED (B)(6) THAT A NEW ASTRAL
DEVICE WILL NOT START AND THE ALARM WAS TRIGGERED AT THE DISTRIBUTOR'S FACILITY.
INVOLVEMENT. MFR REF # 3004604967-2015-00175.|
4809081||NOU|Continuous, Ventilator, Home Use|27051|ASTRAL 100 SC - DEU|
Malfunction|Failure to Power Up|(B)(4).|THE DEVICE WAS SENT TO THE RESMED SERVICE
CENTER IN (B)(4). THE EVAL OF THE RETURNED DEVICE WAS NOT ABLE TO REPRODUCE THE
CUSTOMER ISSUE. THE EVAL CONCLUDED THAT THE DEVICE WAS OPERATING AS DESIGNED. (B)
(4).
EUR4|No answer provided|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED
ITALY THAT AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES, SYSTEM FAULT 74, INDICATING A
SOFTWARE TASK ERROR, AND A POWER SUPPLY FAULT. THIS RESULTED IN AN ALARM WHICH
NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PT INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR REF # 3004604967-2015-00172.|THE DEVICE WAS SENT TO
THE RESMED SERVICE CENTER IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
4809087|20150401|NOU|Continuous, Ventilator, Home Use|27063|ASTRAL 150 EUR4|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED (B)(4)
TECHNICAL SERVICE CENTER THAT DURING SERVICE EVAL AND MAINTENANCE, A SYSTEM FAULT
75 MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING THE PNEUMATIC BLOCK
SOFTWARE IS NOT CALIBRATING. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE THERE WAS NO PT INVOLVEMENT. MFR REF # 3004604967-2015-00169.|
Malfunction|Power Problem;Failure to Power Up|IT WAS REPORTED TO RESMED GERMANY
THAT AN ASTRAL DEVICE HAD NO POWER. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE THERE WAS NO PT INVOLVEMENT. REF MFR # 3004604967-2015-00173.|
Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED FRANCE
TECHNICAL SERVICE CENTER. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT A SYSTEM
FAULT (SF74) MESSAGE INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS
INVOLVEMENT. REFERENCE MFR # 3004604967-2015-00170.|
4821412||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC1|Malfunction|
Device Displays Incorrect Message|PLEASE REFER IMPORTER REPORT# (B)(4).|THE DEVICE
WAS RETURNED TO THE MFG FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING
A SYSTEM FAULT 75 MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING THE
PNEUMATIC BLOCK SOFTWARE IS NOT CALIBRATING. THERE WAS NO PT INJURY REPORTED AS A
Power Problem;Failure To Run On AC/DC|AUTHORIZED DISTRIBUTOR IN (B)(4) REPORTS
DOMESTIC REPAIR OF DEVICE, REPLACING THE POWER SUPPLY UNIT (PSU) BOARD, SINCE THE
PSU BOARD FAILED TO RECOGNIZE AND CHARGE THE INTERNAL BATTERY. BASED ON THE INFO
RECEIVED, THE POTENTIAL RISK ASSOCIATED WITH THE REPORTED EVENT IS CLASSIFIED AS
CRITICAL SINCE A DEPLETED INTERNAL BATTERY WILL EVENTUALLY TERMINATE TREATMENT,
WITH A HIGH PRIORITY VISUAL AND AUDIBLE ALARM. BASED ON THE INFO PROVIDED AT THIS
TIME, INCLUDING UNK PT OUTCOME, THE EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART
803.3.|
Device Displays Incorrect Message|AUTHORIZED DISTRIBUTOR IN (B)(4) REPORTS DOMESTIC
REPAIR OF DEVICE, REPLACING THE POWER SUPPLY UNIT (PSU) BOARD, AFTER HAVING
ENCOUNTERED A FAILURE SHOWING ERROR CODE #39. BASED ON THE INFO RECEIVED, THE
POTENTIAL RISK ASSOCIATED WITH THE REPORTED EVENT IS CLASSIFIED AS CRITICAL SINCE A
FAULTY PSU BOARD MAY CAUSE ERRORS THAT WILL INTENTIONALLY TERMINATE TREATMENT, AS A
RISK MITIGATION, WITH A HIGH PRIORITY ALARM. BASED ON THE INFO PROVIDED AT THIS
TIME, INCLUDING UNK PT OUTCOME, THE EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART
803.3.|
Battery Problem;Failure to Charge;Power Problem|AUTHORIZED DISTRIBUTOR IN (B)(6)
REPORTS DOMESTIC REPAIR OF DEVICE, REPLACING THE POWER SUPPLY UNIT (PSU) BOARD,
SINCE THE PSU BOARD FAILED TO RECOGNIZE AND CHARGE THE INTERNAL BATTERY. BASED ON
THE INFO RECEIVED, THE POTENTIAL RISK ASSOCIATED WITH THE REPORTED EVENT IS
CLASSIFIED AS CRITICAL SINCE A DEPLETED INTERNAL BATTERY WILL EVENTUALLY TERMINATE
TREATMENT, WITH A HIGH PRIORITY VISUAL AND AUDIBLE ALARM. BASED ON THE INFO
PROVIDED AT THIS TIME, INCLUDING UNK PT OUTCOME, THE EVENT IS CONSIDERED REPORTABLE
PER 21 CFR PART 803.3.|
Adverse Event Without Identified Device or Use Problem|(B)(4).|THE RETURNED DEVICE
WAS EVALUATED BY RESMED TECHNICAL SERVICE. THE DEVICE PASSED ALL PERFORMANCE TESTS;
THE FUNCTIONAL INVESTIGATION RESULTED IN "NO FAULT FOUND." THE DEVICE EVENT LOG WAS
DOWNLOADED AND SENT TO THE DESIGN HOUSE IN SYDNEY, AUSTRALIA, FOR REVIEW. THE
DOWNLOADED DEVICE LOG DID NOT SHOW ANY INDICATION OF A DEVICE MALFUNCTION WHICH CAN
POTENTIALLY BE LINKED TO THE PT DEATH. THE DEVICE WAS NOT USED ON THE PT AT THE
TIME OF THE EVENT. (B)(4).
RESMED THAT A (B)(6) CHILD USING AN RESMED ASTRAL DEVICE WAS ADMITTED TO THE
HOSPITAL FOR A PRE-EXISTING SEIZURE DISORDER. UPON ARRIVAL TO THE HOSPITAL, THE
CHILD WAS REMOVED FROM THE ASTRAL DEVICE AND PLACED ON A HOSPITAL OWNED VENTILATOR
UNIT. WHILE IN THE HOSPITAL THE CHILD'S HEALTH DIMINISHED AND SUBSEQUENTLY DIED.
THERE IS NO INDICATION FORM THE HOSPITAL OR STAFF THAT THE ASTRAL DEVICE CAUSED OR
CONTRIBUTED TO THE PT DEATH.|
Malfunction|Battery Problem|IT WAS REPORTED BY RESMED (B)(4) THAT A BATTERY
INOPERABLE EVENT WAS NOTED IN THE ASTRAL DEVICE'S LOG FOLLOWED BY POWER FAILURE AND
RESTART. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR #3004604967-2015-00179.|
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-
2015-00180.|
A SYSTEM FAULT (SF180) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF
THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #3004604967-2015-00183.|
SYSTEM FAULT (SF188) ERROR MESSAGE WAS TRIGGERED IN AN ASTRAL DEVICE DURING THE
INITIAL SET-UP. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE USER OF THE ERROR
MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00184.|
SYSTEM FAULT (SF180) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #3004604967-2015-00181.|
A SYSTEM FAULT (SF101) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING THAT
THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THE SYSTEM FAULT OCCURRED WHILE
THE HOSPITAL MEDICAL STAFF WAS CHANGING THE PATIENT'S CIRCUITS WHEN THE DEVICE IS
STILL IN THERAPY MODE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #3004604967-2015-00182.|
ASTRAL|Malfunction|Low Battery|IT WAS REPORTED TO RESMED (B)(4) THAT A LOW BATTERY
ERROR MESSAGE WAS DISPLAYED WHEN A FULLY CHARGED EXTERNAL BATTERY WAS PLUGGED INTO
THE ASTRAL DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #3004604967-2015-00188.|
EUR4|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(4)
THAT A SYSTEM FAULT 75 MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING THE
PNEUMATIC BLOCK SOFTWARE IS NOT CALIBRATING. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00185.|
VENTILATOR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00187.|
AN ASTRAL DEVICE DISPLAYED AN SYSTEM FAULT 74 ERROR MESSAGE INDICATING A SOFTWARE
TASK ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00189.|
AN ASTRAL DEVICE DISPLAYED AN SYSTEM FAULT 197 ERROR MESSAGE INDICATING OUTLET FLOW
SENSOR FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR #3004604967-2015-00190.|
4834199|20150501|NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SC - DEU|
THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN INVESTIGATION WAS PERFORMED. A
REVIEW OF THE DOWNLOADED ERROR LOGS CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM
FAULT 74 WAS TRIGGERED IN THE DEVICE. ALL INVESTIGATION ATTEMPTS TO REPLICATE THE
FAULT AS WELL AS A VISUAL INSPECTION DETERMINED THE DEVICE IS OPERATING WITHOUT
FAULT. RESMED REFERENCE#: PR884709.(B)(4).
Battery Problem|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECHNICAL
SERVICE. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT AN SF180 ERROR MESSAGE
OCCURRED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4)
Displays Incorrect Message|(B)(4).|PER THE REPORTER, THE DEVICE WAS REBOOTED AND
THE ERROR SELF-CLEARED. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. (B)(4).
Malfunction|Device Displays Incorrect Message|(B)(4).|RESMED HAS REQUESTED FOR THE
Sensing Problem|(B)(4).|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT
TIME. RESMED REFERENCE#: (B)(4).
SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED
DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74 WS
TRIGGERED IN THE DEVICE. VISUAL INSPECTION OF THE DEVICE FOUND AN UNKNOWN SUBSTANCE
ON THE EXPIRATORY VALVE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED
THEN RETURNED TO THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT. (B)(4).
SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. VISUAL INSPECTION OF THE DEVICE
FOUND AN UNKNOWN SUBSTANCE INSIDE THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. (B)(4).
Low Battery|(B)(4).|THE BATTERY WAS RETURNED TO RESMED (B)(4) TECHNICAL SERVICE
CENTER FOR INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE
Leak / Splash|A REPORT WAS RECEIVED STATING A VENTILATOR HAD A SUSPECTED LEAK
DURING VENTILATION OF THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND
PLACED ON AN ALTERNATE DEVICE WITHOUT HARM. THERE IS NO REPORT OF DEATH OR SERIOUS
INJURY ASSOCIATED WITH THIS EVENT.|(B)(4). THE REPORTER STATED THE VENTILATOR WAS
CONNECTED TO A TEST LUNG AND EVENTUALLY VENTILATED THE TEST LUNG AS IT WAS
INTENDED. NO PARTS WERE REPLACED. THE VENTILATOR WAS REPORTED TO BE RETURNED TO
CLINICAL USE.
AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELT-TEST. THIS RESULTED IN AN ALARM
WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00191.|
Displays Incorrect Message|REFERENCE IMPORTER # (B)(4).|THE DEVICE WAS RETURNED TO
THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
IN (B)(4) AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS
CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74, INDICATING A SOFTWARE TASK
ERROR, WAS TRIGGERED IN THE DEVICE. AN UNEXPECTED RESTART OCCURRED AFTER THE HIGH
PRESSURE ALARM WAS TRIGGERED. ALL INVESTIGATION ATTEMPTS TO REPLICATE THE FAULT AS
WELL AS A VISUAL INSPECTION DETERMINED THE DEVICE IS OPERATING WITHOUT FAULT. THE
INVESTIGATION RESULTED IN "NO FAULT FOUND." (B)(4).
IN (B)(4) AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS
DID NOT SHOW ANY EVIDENCE TO THE REPORTED EVENTS. ALL INVESTIGATION ATTEMPTS TO
REPLICATE THE FAULT AS WELL AS A VISUAL INSPECTION DETERMINED THE DEVICE IS
OPERATING WITHOUT FAULT. THE INVESTIGATION RESULTED IN "NO FAULT FOUND." (B)(4).
Displays Incorrect Message|IMP #: 3007573469-2015-00197.|THE DEVICE WAS SENT TO
RESMED TECH SVC CTR IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED TECH SVC.
REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT ERROR MESSAGES SF185 AND SF218 WERE
TRIGGERED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4)
FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. RESMED (B)(4).
Inoperable|(B)(4).|RESMED IS CURRENTLY IN CONTACT WITH THE CUSTOMER AND IS IN THE
PROCESS OF HAVING THE DEVICE RETURNED FOR AN ENGINEERING INVESTIGATION. SINCE THE
DEVICE HAS NOT YET BEEN RETURNED, RESMED IS UNABLE TO CONFIRM THE ALLEGED
MALFUNCTION. WHEN THE DEVICE IS RETURNED TO RESMED AND THE ENGINEERING
INVESTIGATION IS COMPLETED, RESMED WILL PROVIDE A F/U MDR REPORT WITH THE ADD'L
INFO. (B)(4).
Power Problem|(B)(4).|THE POWER CORD WAS RETURNED TO RESMED FRANCE TECH SVC CTR AND
IT WAS FOUND THAT THE POWER CORD WAS NOT WORKING. THE POWER CORD WAS REPLACED TO
ADDRESS THIS ISSUE. (B)(4).
Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO RESMED (B)(4)
TECH SVC CTR FOR INVESTIGATION. FUNCTIONAL TESTING FOUND THAT THE DEVICE IS
OPERATING WITHIN SPECIFICATIONS. THE INVESTIGATION RESULT IS "NO FAULT FOUND." AN
ANALYSIS OF THE DEVICE LOG CONFIRMED THAT AN ERROR MESSAGE SYSTEM FAULT 101
OCCURRED. BASED ON ALL AVAILABLE EVIDENCE IT APPEARS THE ERROR MESSAGE WAS DUE TO
DISCONNECTION OF THE PT CIRCUIT. (B)(4).
Malfunction|Low Battery|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)
(4).
Problem|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
Displays Incorrect Message|IMP #: 3007573469-2015-00199.|THE DEVICE WAS EVALUATED
BY RESMED TECH SVC. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED THAT ERROR MESSAGE
SF101 WAS TRIGGERED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED
IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND
Malfunction|Low Battery|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)
(4).
AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY WHEN THE HIGH PRESSURE ALARM WAS TRIGGERED.
THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #: 3004604967-
2015-00195.|
AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY WHEN THE HIGH PRESSURE ALARM (SF74) WAS
TRIGGERED. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #:
3004604967-2015-00194.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE POWER CORD OF
THE ASTRAL DEVICE IS NOT WORKING. THERE WAS NO PT HARM OR INJURY REPORTED AS A
A SYSTEM FAULT (SF101) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING THAT
THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PT HARM OR INJURY
FRA|Malfunction|Low Battery|IT WAS REPORTED TO RESMED (B)(4) THAT A LOW BATTERY
INDICATOR WAS DISPLAYED IN AN ASTRAL DEVICE EVEN THOUGH THE BATTERY IS FULLY
CHARGED. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#: 3004604967-2015-00200.|
ASTRAL DEVICE DISPLAY DISPLAYED AN ALARM (SF101) INDICATING THAT THE OUTLET
PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PT HARM OR INJURY REPORTED AS A
FRA|Malfunction|Low Battery|IT WAS REPORTED TO RESMED (B)(4) THAT A LOW BATTERY
INDICATOR WAS DISPLAYED IN AN ASTRAL DEVICE EVEN THOUGH THE BATTERY IS FULLY
CHARGED. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#: 3004604967-2015-00196.|
A SYSTEM FAULT (SF188) ERROR OCCURRED ON AN ASTRAL DEVICE. THIS RESULTED IN AN
ALARM WHICH NOTIFIES USER/CAREGIVER TO ERROR MESSAGE. THE DEVICE WAS NOT USED ON A
PT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. MFR #:
3004604967-2015-00197.|
POWER SUPPLY IS DEFECTIVE. IT IS NOT CHARGING THE DEVICE. THERE WAS NO PT INJURY
ERROR MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE. THIS ERROR MESSAGE RESULTED IN AN
ALARM WHICH NOTIFIES CAREGIVER TO THE MALFUNCTION. THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. MFR #: 3004604967-2015-00202.|
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT MULTIPLE ALARMS WERE
TRIGGERED ON AN ASTRAL DEVICE INFORMING THE CAREGIVER THAT THE DEVICE REQUIRED
ATTENTION. PER THE REPORTER THE ALARMS WERE THEN MANUALLY SILENCED BY THE
CAREGIVER. THE DEVICE KEPT ALARMING OVER THE NEXT 26 MINUTES UNTIL IT PERFORMED AN
AUTO SHUTDOWN. THE VENTILATOR DEPENDENT PT THEN REQUIRED AN AMBU BAG UNTIL A BACKUP
VENTILATOR COULD BE CONNECTED. THERE WERE NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR #: 3004604967-2015-00201.|
Problem;Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED (B)(4). A REVIEW OF THE DOWNLOADED ERROR LOGS SHOWED THAT SF180 OCCURRED
DURING VENTILATION. THE DEVICE WILL BE SENT TO RESMED TECHNICAL SERVICES IN (B)(4)
FOR ADDITIONAL INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
RESMED (B)(4) THAT A SYSTEM FAULT (SF180) ERROR, INDICATING A BATTERY CHARGER
FAULT, OCCURRED ON AN ASTRAL DEVICE AND THE VENTILATION STOPPED. PER THE REPORTER,
THE PATIENT WAS MOVED TO ANOTHER VENTILATOR WHEN THE DEVICE ALARM WAS TRIGGERED.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-
2015-00203.|
RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). ADDITIONAL INFO FROM THE
DEVICE INVESTIGATION COMPLETED ON 05/21/2015 DETERMINED THAT A DEVICE MALFUNCTION
CAUSED THE ASTRAL TO FAIL ITS INTERNAL SELF-TEST. THE INVESTIGATION DETERMINED THAT
THE RETURNED DEVICE HAD A BROKEN NON-RETURN VALVE (NRV). THIS ISSUE WOULD NOT ALLOW
THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST IN ANY VALVE CONFIGURATION. RESMED'S
(4).
SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL WAS NOT ABLE TO REPRODUCE
THE CUSTOMER ISSUE; THE RESULT IS "NO FAULT FOUND". (B)(4).
Problem;Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICES IN (B)(4). A REVIEW OF THE DOWNLOADED ERROR LOG SHOWED
THE "BATTERY INOPERABLE" ALARM WAS TRIGGERED. THE DEVICE WAS RETURNED TO THE MFG
SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL SHOWED THAT THE REASON FOR
THE SYSTEM FAULT WAS THE BATTERY WAS FULLY DISCHARGED WHEN IT ARRIVED AT THE
DISTRIBUTOR'S SITE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED THEN
RETURNED TO THE CUSTOMER. (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4)
TECHNICAL SERVICE CENTER. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED ERROR MESSAGES
WERE TRIGGERED ON THE ASTRAL DEVICE. THE DEVICE IS CURRENTLY BEING RETURNED TO THE
MFG FACILITY IN (B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE
DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE
ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN(B)(4). ADDITIONAL INFO FROM
THE DEVICE INVESTIGATION COMPLETED ON 05/21/2015 DETERMINED THAT A DEVICE
MALFUNCTION CAUSED THE ASTRAL TO FAIL ITS INTERNAL SELF-TEST. THE INVESTIGATION
DETERMINED THAT THE RETURNED DEVICE HAD A BROKEN NON-RETURN VALVE (NRV). THIS ISSUE
WOULD NOT ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST IN ANY VALVE
ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). ADDITIONAL INFO FROM
ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). ADDITIONAL INFO FROM
THAT THE RETURNED DEVICE HAD A BROKEN NON-RETURN VALVE (NRV). THIS ISSUE WOULD NOT
ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST IN ANY VALVE CONFIGURATION.
RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Device Displays Incorrect Message;Battery Problem|(B)(4).|THE DEVICE WAS RETURNED
TO THE MFG FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
Pressure Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES
IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG
CONFIRMED THAT A SINGLE OCCURRENCE OF A RESTART FROM A HIGH PRESSURE ALARM WAS
TRIGGERED IN THE DEVICE. VISUAL INSPECTION OF THE DEVICE FOUND AN UNK FOREIGN
SUBSTANCE, MOST LIKELY DRUG RESIDUE, IN THE HOSE AND FLOW SENSORS. THE DEVICE WAS
CLEANED, SERVICED, CALIBRATED AND TESTED THEN RETURNED TO THE CUSTOMER. THERE WAS
NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE DURING INCOMING INSPECTION AT THE
DISTRIBUTOR SITE. THIS RESULTED IN AN ALARM NOTIFYING THE USER OF THE ERROR
MESSAGE. THE DEVICE WAS NOT USED ON A PT WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PT INVOLVEMENT.|
Malfunction|Failure to Calibrate|AN ASTRAL DEVICE WAS RETURNED TO RESMED (B)(4) FOR
A RESULT OF THIS INCIDENT.|
FAILING TO PASS ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT USED ON A PT WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES. THIS RESULTED IN AN ALARM
NOTIFYING THE USER OR CAREGIVER OF THE ERROR MESSAGES. THERE WAS NO PT HARM OR
FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. ADDITIONAL INFO FROM THE
CAUSED THE ASTRAL TO FAIL ITS INTERNAL SELF-TEST.|
FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. ADDITIONAL INFO FROM THE
CAUSED THE ASTRAL TO FAIL ITS INTERNAL SELF-TEST.|
RESMED (B)(4) THAT A BATTERY INOPERABLE ERROR MESSAGE WAS DISPLAYED ON AN ASTRAL
DEVICE. THIS ERROR MESSAGE RESULTED IN AN ALARM WHICH NOTIFIES CAREGIVER TO THE
MALFUNCTION. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE DURING INCOMING INSPECTION AT THE
DISTRIBUTOR SITE. THIS RESULTED IN AN ALARM NOTIFYING THE USER OF THE ERROR
MESSAGE. THE DEVICE WAS NOT USED ON A PT WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PT INVOLVEMENT.|
RESTARTED AFTER THE HIGH PRESSURE ALARM WAS TRIGGERED. THERE WAS NO PT HARM OR
RESMED (B)(4) THAT AN ASTRAL DEVICE HAD AN ERROR MESSAGE WITH AN UNEXPECTED
RESTART. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
4872332|20150602|NOU|Continuous, Ventilator, Home Use|HT70M|HT70 VENTILATOR|Injury|
Device Inoperable|IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR
SILENCE/RESET BUTTON WAS UNRESPONSIVE. THE PATIENT WAS REMOVED FROM THE VENTILATOR
AND TRANSFERRED TO ANOTHER VENTILATOR WITHOUT ANY REPORTED HARM. THERE IS NO REPORT
OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.|(B)(4).IT WAS REPORTED BY
THE CUSTOMER THAT THE REPORTED CONDITION WAS DUPLICATED. THE ALARM OCCURRED AT
SHUTDOWN AND COULD NOT BE CANCELED ALTHOUGH THE BUTTON WAS PRESSED SEVERAL TIMES.
IT HAS ALSO BEEN REPORTED THAT THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT YET
BEEN COMPLETED.
A HIGH PRESSURE ALARM OCCURRED ON AN ASTRAL DEVICE RESULTING IN THE DEVICE
RESTARTING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
AN ALARM WAS TRIGGERED ON AN ASTRAL DEVICE NOTIFYING THE USER OF ERROR MESSAGES.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
Inappropriate or Unexpected Reset;Device Displays Incorrect Message|(B)(4).|THE
DEVICE WAS RECEIVED BY RESMED (B)(4). THE DEVICE IS CURRENTLY BEING SENT TO RESMED
TECHNICAL SERVICE CENTER IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
(4).
SERVICES IN (B)(4). A REVIEW OF THE DOWNLOADED DEVICE ERROR LOG CONFIRMED THAT A
HIGH PRESSURE ALARM WAS TRIGGERED IN THE DEVICE BUT THERE WAS NO EVIDENCE OF A
DEVICE RESTART OCCURRING. THE DEVICE IS CURRENTLY BEING RETURNED TO THE
PERFORMED. (B)(4).
Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY IN SYDNEY, AUSTRALIA SO THAT AN ENGINEERING INVESTIGATION
CAN BE PERFORMED. THE DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE
TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
Malfunction|Inappropriate or Unexpected Reset;Device Displays Incorrect Message|IT
WAS REPORTED TO RESMED UNITED KINGDOM THAT AN ASTRAL DEVICE DISPLAYED A BATTERY
INOPERABLE ERROR MESSAGE, THEN THE DEVICE ALARMED AND RESTARTED. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED (B)(6) THAT A PATIENT
MANUALLY STOPPED THE VENTILATION ON AN ASTRAL DEVICE AND WAS UNABLE TO RESTART THE
DEVICE 15 MINUTES LATER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|
Malfunction|Inappropriate or Unexpected Reset|IT WAS REPORTED TO RESMED (B)(6) THAT
AN ASTRAL DEVICE STOPPED AND RESTARTED. THERE WAS NO PATIENT INJURY REPORTED AS A
AN ASTRAL DEVICE DISPLAYED AN ALARM (SF101) INDICATING THAT THE OUTLET PRESSURE
MEASUREMENT MAY BE INCORRECT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE
CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|
Malfunction|Inappropriate or Unexpected Reset|DURING A TECHNICAL SERVICE EVALUATION
OF THE ASTRAL DEVICE THE DIAGNOSTIC LOGS WERE EVALUATED. AN UNEXPECTED DEVICE
RESTART WAS DETECTED IN THE LOG ENTRIES DURING THE EVALUATION. THERE WAS NO PATIENT
Malfunction|Charging Problem;Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICES INTERNAL BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS
4881377|20150501|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150- DEU|
TASK ERROR. THE MESSAGE RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER TO THE
MALFUNCTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
Failure to Power Up|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
IN (B)(4) SO AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT YET
BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT
THIS TIME. (B)(4).
Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO THE
MANUFACTURING FACILITY IN SYDNEY, AUSTRALIA SO THAT AN ENGINEERING INVESTIGATION
CAN BE PERFORMED. THE DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE
TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
4881386||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - AMER|Malfunction|Power
Problem;Charging Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY IN (B)(4) STRALIA SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED.
THE DEVICE HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE
4881387||NOU|Continuous, Ventilator, Home Use||ASTRAL 150- DEU|Malfunction|Device
SERVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74 WAS
TRIGGERED IN THE DEVICE. THE SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES
STAFF COULD NOT REPRODUCE THE FAULT. (B)(4).
Alarm System|IMP #(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES
IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS DID NOT
CONFIRM A SYSTEM FAILURE IN THE DEVICE WHICH TRIGGERED THE ALARM. ALL INVESTIGATION
ATTEMPTS TO REPLICATE THE FAULT AS WELL AS A VISUAL INSPECTION DETERMINED THE
DEVICE IS OPERATING WITHOUT FAULT. BASED ON THE INFO PROVIDED BY THE USER, IT IS
POSSIBLE THAT THE LOW PEEP PRESSURE WARNING ALARM WAS TRIGGERED DUE TO A LEAK IN
THE CIRCUIT DURING USE. (B)(4).
Malfunction|Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO
THE RESMED (B)(4) TECHNICAL SERVICE CENTER. A PRELIMINARY EVAL SHOWED THAT THE
BATTERY WAS NOT CHARGING. THE DEVICE WAS RETURNED TO THE MFG FACILITY IN (B)(4)SO
THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT YET BEEN
RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS
TIME. RESMED REF(B)(4).
4898552|20150601|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - DEU|
Malfunction|Failure to Calibrate|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4)
TECHNICAL SERVICE CENTER. THE EVAL DETERMINED THAT THE DEVICE FAILURE TO COMPLETE
ITS INTERNAL SELF-TEST WAS DUE TO A PNEUMATIC BLOCK MALFUNCTION. THE PNEUMATIC
BLOCK WAS REPLACED TO RESOLVE THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
Problem|(B)(4).|THE PSU IS CURRENTLY BEING RETURNED TO THE MFG FACILITY LOCATED IN
(B)(4) FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AS THIS STAGE. RESMED REF # (B)(4).
Malfunction|Power Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE
EVENTS LOG CONFIRMED THAT SYSTEM FAULT 180 WAS TRIGGERED IN THE DEVICE. THE SYSTEM
FAULT WAS REPRODUCED DURING DEVICE EVAL. THE DEVICE WAS RETURNED TO THE MFG
FACILITY IN (B)(4)SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE
HAS NOT YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED
MALFUNCTION AT THIS TIME. RESMED REFERENCE # (B)(4).
4898562||NOU|Continuous, Ventilator, Home Use||ASTRAL EXTERNAL BATTERY, ROW|
Malfunction|Battery Problem;Power Problem|IMP # (B)(4).|THE EXTERNAL BATTERY WAS
SENT TO THE RESMED TECHNICAL SERVICES IN (B)(4) FOR INVESTIGATION. THE
(4).
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED (B)(4) THAT AS ASTRAL
DEVICE DISPLAYED A CONTINUOUS WARNING ALARM OF LOW PEEP PRESSURE AT THE DISTRIBUTOR
SITE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).|
AN ASTRAL DEVICE RESET. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR REF # 3004604967-2015-00239.|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT
(SF180) OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER FAULT. THIS
RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THE DEVICE
WAS NOT USED ON A PT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PT
INVOLVEMENT. MFR # 3004604967-2015-00240.|
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(4) TECHNICAL SERVICE
CENTER THAT DURING SERVICE EVAL AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-
TEST. THE DEVICE WAS NOT USED ON A PT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PT INVOLVEMENT. MFR # 3004604967-2015-00241.|
VENTILATOR'S POWER SUPPLY CONNECTOR WAS DEFECTIVE. THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00243.|
4898600|20150601|NOU|Continuous, Ventilator, Home Use|27918|ASTRAL EXTERNAL
BATTERY, ROW|Malfunction|Battery Problem;Power Problem|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL DEVICE'S EXTERNAL BATTERY LOSES CONNECTION WITH DEVICE. THERE
WAS NO PT HARM OR INJURY REPORTED FOR THIS INCIDENT. MFR # 3004604967-2015-00242.|
4902070||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SC- DEU|Malfunction|
Inappropriate or Unexpected Reset;Device Displays Incorrect Message|IMPORTER REF#
(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(6) AND AN
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED A
SINGLE OCCURRENCE OF SYSTEM FAULT 218 AND SYSTEM FAULT 74. THE SYSTEM TESTING
PERFORMED BY THE TECHNICAL SERVICES STAFF COULD NOT REPRODUCE THE FAULT; THE RESULT
IS "NO FAULT FOUND." (B)(4).
Inappropriate or Unexpected Reset;Device Displays Incorrect Message|IMPORTER REF#
(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(6) AND AN
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED
THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 218 WAS TRIGGERED IN THE DEVICE. THE
SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES STAFF COULD NOT REPRODUCE THE
FAULT; THE RESULT IS "NO FAULT FOUND." (B)(4).
Power Problem|IMPORTER REF# (B)(4).|THE POWER SUPPLY WAS RETURNED TO RESMED (B)(4)
TECHNICAL SERVICE CENTER AND IT WAS FOUND THAT THE POWER SUPPLY WAS NOT WORKING.
THE POWER SUPPLY WAS REPLACED TO ADDRESS THIS ISSUE. (B)(4).
Charging Problem|(B)(4).|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
(4).
Charging Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES
IN (B)(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4).
4902106||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SC- DEU|Malfunction|
Device Displays Incorrect Message;Inappropriate or Unexpected Reset|IMPORTER REF
#(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(6) AND AN
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED
THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 218 WAS TRIGGERED IN THE DEVICE. THE
SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES STAFF COULD NOT REPRODUCE THE
FAULT; THE RESULT IS "NO FAULT FOUND." (B)(4).
Device Displays Incorrect Message;Battery Problem|(B)(4).|THE DEVICE WAS RETURNED
TO THE MANUFACTURING FACILITY IN (B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION
WAS PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED THAT A SINGLE
OCCURRENCE OF SYSTEM FAULT 218 WAS TRIGGERED IN THE DEVICE. THE SYSTEM TESTING
PERFORMED BY THE TECHNICAL SERVICES STAFF COULD NOT REPRODUCE THE FAULT; THE RESULT
IS "NO FAULT FOUND." (B)(4).
Charging Problem|IMPORTER REF# (B)(4).|THE DEVICE WAS RETURNED TO RESMED AND THE
REPORTED BATTERY CHARGING ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE
WAS A FAILURE OF THE BATTERY CHARGING CIRCUITRY. (B)(4).
Displays Incorrect Message;Inappropriate or Unexpected Reset|IMPORTER REF# (B)(4).|
THE CUSTOMER CONTACTED RESMED TECHNICAL SUPPORT TO REQUEST ASSISTANCE REGARDING AN
ALARM THAT WAS TRIGGERED ON AN ASTRAL DEVICE THAT RESULTED IN THE DEVICE
RESTARTING. THE TECHNICAL SUPPORT STAFF REVIEWED THE ASTRAL CLINICAL GUIDE WITH THE
CUSTOMER TO RESOLVE THIS ISSUE. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION.
(B)(4).
Malfunction|Device Displays Incorrect Message;Inappropriate or Unexpected Reset|IT
WAS REPORTED TO RESMED (B)(4) THAT DURING INCOMING INSPECTION AT THE DISTRIBUTOR
SITE, A SYSTEM FAULT OCCURRED ON THE AN ASTRAL DEVICE AND THE DEVICE RESTARTED. THE
DEVICE WAS NOT USED ON A PATIENT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|
WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT OCCURRED ON AN ASTRAL DEVICE AND
THE DEVICE RESTARTED DURING INCOMING INSPECTION AT THE DISTRIBUTOR SITE. THE DEVICE
WAS NOT USED ON A PATIENT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT.|
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE "BATTERY
INOPERABLE." THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
POWER SUPPLY IS DEFECTIVE. IT IS NOT CHARGING THE DEVICE. THERE WAS NO PATIENT
4902184|20150601|NOU|Continuous, Ventilator, Home Use|27918|BATTERIES EXTERNE
DEVICE HAD AN INTERNAL BATTERY THAT WAS NOT CHARGING PROPERLY. THERE WAS NO PATIENT
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE
HAD INTERNAL BATTERY THAT WAS NOT CHARGING PROPERLY. THERE WAS NO PATIENT INJURY
HAD AN INTERNAL BATTERY THAT WAS NOT CHARGING PROPERLY. THERE WAS NO PATIENT INJURY
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A SYSTEM ALARM THAT RESULTED IN
THE DEVICE PERFORMING A RESTART. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|
Device Displays Incorrect Message;Loss of Power|IT WAS REPORTED THAT DURING PATIENT
USE,THE VENTILATOR SUDDENLY GENERATED AN ALARM AND SHUT ITSELF DOWN. THE PATIENT
WAS REMOVED FROM THE VENTILATOR AND TRANSFERRED TO ANOTHER VENTILATOR WITHOUT ANY
REPORTED PATIENT HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASOCIATED
WITH THIS EVENT.|(B)(4).
BATTERY, ROW|Malfunction|Charging Problem;Battery Problem|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL EXTERNAL BATTERY DOES NOT CHARGE. THERE WAS NO PATIENT HARM
OR INJURY REPORTED FOR THIS INCIDENT. MFR# 3004604967-2015-00246.|
Malfunction|Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ERROR MESSAGE WHICH RESULTED IN A
POWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR# 3004604967-2015-00249.|
Malfunction|Charging Problem;Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT
AN ASTRAL DEVICE'S BATTERY IS NOT CHARGING. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00252.|
CENTER THAT DURING SERVICE EVALUATION AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL
SELF-TEST. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. MFR# 3004604967-2015-00253.|
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO RESMED CORP IN (B)
(4). THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS
STAGE. (B)(4).
to Calibrate|IMP# (B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4) TECHNICAL
SERVICE CENTER. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A PNEUMATIC BLOCK MALFUNCTION. THE PNEUMATIC BLOCK
WAS REPLACED TO RESOLVE THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Charging Problem;Failure to Charge|IMP# (B)(4).|THE DEVICE WAS EVALUATED BY RESMED
(B)(4) TECHNICAL SERVICE CENTER. THE EVALUATION CONFIRMED THAT THE RETURNED ASTRAL
DEVICE WILL NOT CHARGE. EVALUATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE
WAS A FAULTY POWER SUPPLY UNIT (PSU). (B)(4).
Stops Intermittently;Battery Problem|IMP# (B)(4).|THE ASTRAL DEVICE WAS RETURNED TO
RESMED TECHNICAL SERVICES AND AN INVESTIGATION WAS PERFORMED. REVIEW OF THE
DOWNLOADED THERAPY DATA SHOWED THAT THE EXTERNAL POWER DISCONNECT ALARM WAS
ACTIVATED WHICH RESULTED IN THE BATTERY DEPLETING TO 0%. BASED ON THE INFORMATION
AVAILABLE TO RESMED, THIS REPORTED ISSUE WAS RELATED TO A BATTERY FAILURE. (B)(4).
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE WILL NOT RESTART AFTER THE TECHNICIAN STOPPED THE DEVICE. THIS MALFUNCTION
OCCURRED DURING DEVICE SET-UP AT THE CUSTOMER'S WAREHOUSE. THE DEVICE WAS NOT USED
ON A PATIENT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
MFR# 3004604967-2015-00244.|
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE "CIRCUIT ERROR" AND THE DEVICE WILL NOT
START VENTILATION. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE USER OF THE
MALFUNCTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR#3004604967-2015-00245.|
Malfunction|Calibration Problem|AN ASTRAL DEVICE WAS RETURNED TO RESMED (B)(4)
SERVICE CENTER FOR SERVICE DUE TO A CIRCUIT PROBLEM. THERE WAS NO PATIENT HARM OR
INJURY REPORTED FOR THIS INCIDENT. MFR# 3004604967-2015-00247.|
Malfunction|Failure to Calibrate|AN ASTRAL DEVICE WAS RETURNED TO THE RESMED (B)(4)
SERVICE CENTER AFTER A FLOW SENSOR FAULT OCCURRED DURING AN INTERNAL SELF-TEST.
THERE WAS NO PATIENT HARM OR INJURY REPORTED FOR THIS INCIDENT. MFR# 3004604967-
2015-00248.|
Malfunction|Pressure Problem;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE MALFUNCTIONED AND SOUNDED AN AUDIBLE ALARM. THE
PATIENT UNPLUGGED THE DEVICE AND ALLOWED THE BATTERY TO DEPLETE TO STOP THE ALARM.
THIS CAUSE A SYSTEM FAILURE 74 AND A TOTAL POWER FAILURE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00251.|
Malfunction|Failure to Charge;Charging Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE WILL NOT CHARGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED
AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00254.|
Malfunction|Device Stops Intermittently;Battery Problem|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL DEVICE HAD A LOW BATTERY CAUSING AN ALARM. THIS RESULTED IN
AN INDEPENDENT SHUT DOWN OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00255.|
Device Inoperable|(B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN
(B)(4) SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT
YET BEEN RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION
Malfunction|Charging Problem;Battery Problem|(B)(4).|THE EXTERNAL BATTERY WAS
RECEIVED BY RESMED (B)(4) TECHNICAL SERVICE CENTER FOR INVESTIGATION. THE
(4).
Calibration Problem|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4) TECHNICAL
SERVICE CENTER. THE EVALUATION DETERMINED THAT THE REPORTED CIRCUIT PROBLEM WAS DUE
TO A PNEUMATIC BLOCK ISSUE. THE PNEUMATIC BLOCK WAS REPLACED, THE DEVICE WAS
CLEANED, SERVICED, AND CALIBRATED TO RESOLVE THE ISSUE. (B)(4).
Charging Problem;Battery Problem|(B)(4).|THE DEVICE WAS RETURNED TO RESMED CORP IN
(B)(4) AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DOWNLOADED DEVICE LOG SHOWED
A SINGLE OCCURRENCE OF SYSTEM FAULT 180 INDICATING A BATTERY CHARGER FAULT. THE
DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED TO THE
CUSTOMER. (B)(4).
4915516||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - APAC|Malfunction|
Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL CENTER
IN (B)(4). DURING THE EVALUATION OF THE DEVICE IT WAS FOUND THAT THE DEVICE OUTLET
FLOW SENSOR OFFSET VALUE HAD DRIFTED FROM ITS ORIGINAL VALUES. THIS RESULTED IN THE
DEVICE SENSING AN ERROR THAT WAS OVER THE DEVICE FLOW SENSING TOLERANCE. THE
DRIFTING OF THE FLOW SENSOR WILL CAUSE AN ERROR ALARM. THE ROOT CAUSE OF THE
MALFUNCTION WAS THE DUE TO AN ERROR IN THE EXPIRATORY FLOW SENSOR WHICH RESULTED IN
THE DEVICE GENERATING THE ALARM. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IF ACCEPTABLE. (B)(4).
Charging Problem;Battery Problem|IMP# (B)(4).|THE DEVICE WAS EVALUATED BY RESMED
(B)(4) TECHNICAL SERVICE CENTER AND THE REPORTED BATTERY CHARGING ISSUE WAS
CONFIRMED. THE BATTERY WAS REPLACED, THE DEVICE WAS CLEANED, SERVICED, AND
CALIBRATED TO RESOLVE THE ISSUE. (B)(4).
Displays Incorrect Message;Pressure Problem|IMP# (B)(4).|NO DEVICE WAS RETURNED TO
RESMED FOR INVESTIGATION. THE CUSTOMER INFORMED RESMED TECHNICAL SUPPORT OF AN
OBSERVED SYSTEM FAULT 74, A HIGH PRESSURE OBSTRUCTION ALARM, IN AN ASTRAL DEVICE.
THE CUSTOMER WAS THEN INFORMED OF THE ROOT CAUSES FOR A HIGH PRESSURE OBSTRUCTION
ALARM INCLUDING PATIENT SETTINGS OR A KINK IN THE TUBING. THE PATIENTS DEVICE WAS
REBOOTED AND PUT THROUGH A SUCCESSFUL LEARN CIRCUIT WHICH RESOLVED THE ISSUE. THERE
WERE NO ADVERSE EVENTS REPORTED FOR THIS INCIDENT. (B)(4).
Problem|REFERENCE IMPORTER # (B)(4).|THE PSU WAS RECEIVED BY RESMED (B)(4) AND WAS
EVALUATED BY TECHNICAL SERVICES. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE A
POWER SUPPLY UNIT FAILURE, AND IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN SYDNEY, AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE POWER
SUPPLY UNIT HAS BEEN REPLACED TO ADDRESS THIS ISSUE. (B)(4).
POWER SUPPLY UNIT (PSU) WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT. REFERENCE MFR # 3004604967-2015-00257.|
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT HARM OR INJURY
VENTILATOR'S POWER SUPPLY CONNECTOR WAS DEFECTIVE. THERE WAS NO PT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|
Failure to Calibrate|(B)(4).|THE DEVICE WAS SENT TO (B)(4) FOR INVESTIGATION. THE
(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED CORP THAT AN ASTRAL
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT INJURY REPORTED AS A
4929434|20150601|NOU|Continuous, Ventilator, Home Use||PSU -ASTRAL|Malfunction|
Power Problem|(B)(4).|THE POWER SUPPLY WAS RETURNED TO (B)(4) AND AN EVAL WAS
PERFORMED. INSPECTION OF THE POWER SUPPLY SHOWED THAT THE CONNECTORS IN THE PLUG
HAVE MOVED AND ARE NOT PROVIDING THE REQUIRED CONNECTION. THE PSU WAS REPLACED TO
ADDRESS THE ISSUE. (B)(4).
Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL DETERMINED THAT THE DEVICE
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A PNEUMATIC BLOCK
MALFUNCTION. THE PNEUMATIC BLOCK WAS REPLACED WHICH RESOLVE THE ISSUE. THE DEVICE
WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED TO THE CUSTOMER.
RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.
(B)(4).
Pressure Problem|(B)(4).|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IS CURRENTLY
AT THIS STAGE. RESMED REFERENCE#: (B)(4).
Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO THE TECHNICAL
DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74 WAS
TRIGGERED IN THE DEVICE. THE SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES
STAFF COULD NOT REPRODUCE THE FAULT. THE DEVICE WAS CLEANED, SERVICED, AND
CALIBRATED THEN RETURNED TO THE CUSTOMER. RESMED REFERENCE#: (B)(4).
SERVICES IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE TECHNICAL
EVALUATION CONFIRMED THE REPORTED SELF-TEST FAILURE. THE INVESTIGATION IDENTIFIED
THE ROOT CAUSE OF THIS SYSTEM FAULT TO BE A DEFECTIVE PNEUMATIC BLOCK. TO RESOLVE
THIS ISSUE, THE DEVICE SOFTWARE WAS UPGRADED AND THE PNEUMATIC BLOCK COMPONENT WAS
REPLACED. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. RESMED REFERENCE#: (B)(4).
SERVICES IN (B)(4) AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED
ERROR LOGS CONFIRMED THAT A SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE. ALL
INVESTIGATION ATTEMPTS TO REPLICATE THE FAULT AS WELL AS A VISUAL INSPECTION
DETERMINED THE DEVICE IS OPERATING WITHOUT FAULT. THE DEVICE WAS RETURNED TO THE
CUSTOMER AFTER EVALUATION. REDMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).
Pressure Problem|(B)(4).|THE DEVICE WAS RETURNED TO (B)(4) AND AN EVALUATION WAS
PERFORMED. A REVIEW OF THE DOWNLOADED DEVICE ERROR LOG CONFIRMED THAT A HIGH
PRESSURE ALARM WAS TRIGGERED IN THE DEVICE CAUSING IT TO RESET. THE TECHNICAL
INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED COMPLAINT AS A FAILURE OF
THE MAIN CIRCUIT BOARD (PCB). THE ISSUE WAS RESOLVED BY REPLACING THE PCB. RESMED
HAS CONDUCTED A STATISTICAL ANALYSIS FOR THIS FAILURE MODE ALONG WITH PERFORMING A
SAFETY RISK ANALYSIS AND CONCLUDED THAT THE RISK IS ACCEPTABLE. (B)(4).
4932858||NOU|Continuous, Ventilator, Home Use||ASTRAL 150- DEU|Malfunction|
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS CONFIRMED THAT A
SINGLE OCCURRENCE BATTERY ALARM WAS TRIGGERED WHEN THE BATTERY WAS EMPTY, CAUSING
THE UNEXPECTED RESTART. THE INVESTIGATION WAS NOT ABLE TO REPRODUCE THE CUSTOMER
ISSUE AND THE DEVICE WAS SHIPPED BACK AS "NO FAULT FOUND". (B)(4).
4932859||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 DEU|Malfunction|Battery
Problem;Device Displays Incorrect Message|(B)(4).|THE ASTRAL DEVICE WAS RETURNED TO
(B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR
LOGS CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 180, INDICATING A BATTERY
CHARGER FAULT, WAS TRIGGERED. THE TECHNICAL INVESTIGATION FOUND THE ROOT CAUSE TO
BE THE MAIN CIRCUIT BOARD (PCB). THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE TO
ADDRESS THIS ISSUE. THERE WERE NO ADVERSE EVENTS REPORTED FOR THIS INCIDENT. (B)
(4).
Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(6) AND A PRELIMINARY EVALUATION WAS PERFORMED. A REVIEW
OF THE DOWNLOADED ERROR LOGS CONFIRMED A SINGLE OCCURRENCE OF DEVICE RESTART. THE
INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE WAS A SOFTWARE FAULT.
(B)(4).
No Display / Image;Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS
RETURNED TO (B)(4) AND IS CURRENTLY BEING RETURNED TO (B)(4) SO THAT AN ENGINEERING
INVESTIGATION CAN BE PERFORMED. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
SERVICES AND A PRELIMINARY EVALUATION WAS PERFORMED. AN ANALYSIS OF THE DEVICE LOG
CONFIRMED A SINGLE SYSTEM FAULT OCCURRENCE. THE EVALUATION DETERMINED THAT SYSTEM
FAULT (SF) 101 DESCRIBING AN INCORRECT OUTLET PRESSURE MEASUREMENT WAS TRIGGERED.
THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED RISK ANALYSIS FOR
4932897|20150601|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DB1 KIT FRA|
Malfunction|Pressure Problem|IT WAS REPORTED TO (B)(4) THAT THE PRESSURE ON AN
ASTRAL DEVICE WAS INCREASING BEYOND IT'S SCRIPTED LIMITS. THIS RESULTED IN AN
AUDIBLE ALARM WITH THE ERROR MESSAGE "CIRCUIT FAILURE". THERE WAS NO PATIENT INJURY
WAS REPORTED TO (B)(4) THAT AN ASTRAL DEVICE'S BATTERY ALARM WAS TRIGGERED. THERE
WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
(B)(4) THAT A SYSTEM FAULT (SF180) OCCURRED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT. THE MESSAGE RESULTED IN AN AUDIBLE ALARM AND CAUSED THE
DEVICE TO SHUT DOWN. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|
4932905|20150601|NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DB1 KIT FRA|
(B)(4) THAT THE ASTRAL DEVICE HAD A NON-FUNCTIONING TOUCHSCREEN WITH AN AUDIBLE
ALARM AFTER BEING PLUGGED INTO MAIN POWER. THERE WAS NO PATIENT HARM OR INJURY
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED CORP. THAT AN ASTRAL
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST (LEARN CIRCUIT). THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO (B)(4) THAT AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 ERROR MESSAGE INDICATING A SOFTWARE TASK
ERROR. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO
RESTARTED AFTER THE HIGH PRESSURE ALARM WAS TRIGGERED. THERE WAS NO PATIENT INJURY
Malfunction|Inappropriate or Unexpected Reset|IT WAS REPORTED TO (B)(4) THAT AN
ASTRAL DEVICE HAD AN UNEXPECTED RESTART. THERE WAS NO PATIENT HARM OR INJURY
NURSE ATTENDING TO AN ASTRAL PATIENT REMOVED THE VENTILATOR FOR PATIENT SUCTIONING
AND WHILE RECONNECTING THE PATIENT TO THE VENTILATOR REALIZED IT HAD SHUT DOWN. THE
DEVICE DISPLAYED A SYSTEM FAULT ERROR MESSAGE THAT STATED "RETURN FOR SERVICE".
THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A PNEUMATIC BLOCK
MALFUNCTION. THE PNEUMATIC BLOCK WAS REPLACED WHICH RESOLVE THE ISSUE. RESMED'S
Displays Incorrect Message;Inappropriate or Unexpected Reset|(B)(4).|RESMED HAS
REQUESTED THE DEVICE BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD NOT BE
PERFORMED. A RESMED REP HAS BEEN TRYING TO CONTACT THE REPORTER TO GATHER MORE INFO
REGARDING THE MALFUNCTION INCIDENT AND THE DEVICE DETAILS. AT THE TIME OF THIS
REPORT, NO CONTACT HAS BEEN MADE WITH THE REPORTER, AND THE DEVICE HAS NOT BEEN
RETURNED, THEREFORE NO DEVICE INVESTIGATION HAS OCCURRED. (B)(4).
ASTRAL DEVICE WAS RETURNED TO RESMED TECHNICAL SERVICES AND AN INVESTIGATION WAS
PERFORMED. REVIEW OF THE DOWNLOADED THERAPY DATA SHOWED THAT A SYSTEM FAULT 180,
INDICATING A BATTERY CHARGER FAULT, AS TRIGGERED. THE DEVICE IS CURRENTLY BEING
(B)(4).
THE MFG FACILITY IN (B)(6) SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED.
RESMED REF # (B)(4).
to Calibrate|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4). THE EVAL DETERMINED
THAT THE DEVICE FAILURE WAS DUE TO A PNEUMATIC BLOCK MALFUNCTION. THE PNEUMATIC
BLOCK WAS REPLACED TO RESOLVE THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
CENTER THAT DURING SERVICE EVAL, AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-
TEST. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
WAS UNABLE TO POWER UP AFTER BEING CHARGED. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
WAS REPORTED TO RESMED CORP., THAT THE ASTRAL DEVICE STOPPED VENTILATION. PER THE
REPORTER, THE PT'S VENTILATOR SHUT DOWN DURING USE AFTER AN AUDIBLE ALARM SOUNDED
THREE TIMES. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF 180) WAS OBSERVED ON AN
ASTRAL DEVICE INDICATING A TOTAL POWER FAILURE. THE DEVICE EXPECTEDLY RESTARTED AS
A RESULT OF THIS INCIDENT. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|
Problem|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4)
AND AN EVAL WAS PERFORMED. THE PRELIMINARY EVAL IDENTIFIED THE ROOT CAUSE OF THE
SYSTEM FAULT TO BE A POWER SOURCE FAILURE. THE DEVICE IS BEING RETURNED TO THE MFG
FACILITY (B)(4) FOR AN ENGINEERING INVESTIGATION. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(4) THAT AN ASTRAL
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST DURING INCOMING INSPECTION. THE DEVICE
WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). ADDITIONAL INFORMATION FROM THE DEVICE
INVESTIGATION DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO FAIL ITS
INTERNAL SELF-TEST. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS DUE
TO A LEAK ON THE NON-RETURN VALVE (NRV). THIS ISSUE WOULD NOT ALLOW THE DEVICE TO
COMPLETE ITS INTERNAL SELF-TEST. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). ADDITIONAL
INFORMATION FROM THE DEVICE INVESTIGATION DETERMINED THAT A DEVICE MALFUNCTION
CAUSED THE ASTRAL TO FAIL ITS INTERNAL SELF-TEST. THE INVESTIGATION DETERMINED THAT
THE REPORTED FAILURE WAS DUE TO A LEAK ON THE NON-RETURN VALVE (NRV). THIS ISSUE
WOULD NOT ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST. RESMED'S RISK
Malfunction|Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT
AN ASTRAL DEVICE IS NOT CHARGING. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IS CURRENTLY
AN ASTRAL DEVICE'S ALARM WAS TRIGGERED WHICH NOTIFIED THE CAREGIVER TO THE
4943642||NOU|Continuous, Ventilator, Home Use||ASTRAL 150- DEU|Malfunction|Failure
to Calibrate|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4) TECHNICAL SERVICE
CENTER. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A PNEUMATIC
BLOCK MALFUNCTION. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THE ISSUE. RESMED'S
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED
REFERENCE#: (B)(4).
Display / Image;Device Inoperable|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION SHOWED
THAT THE DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS RETURNED
TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
(B)(4).
PERFORMED. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4).
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM OR INJURY
Malfunction|No Display / Image;Device Inoperable|IT WAS REPORTED TO RESMED THAT
WHILE THE ASTRAL DEVICE WAS IN STANDBY MODE THE DISPLAY SCREEN FROZE AND THE DEVICE
BECAME INOPERABLE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|
Device Displays Incorrect Message|IT WAS REPORTED THAT DURING PATIENT USE, A
VENTILATOR SUDDENLY SOUNDED AN ALARM. AN INTERNAL PRESSURE TRANSDUCER ERROR WAS
CONFIRMED. THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED AND
TRANSFERRED TO ANOTHER VENTILATOR. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH
ASSOCIATED WITH THIS EVENT.|(B)(4).
4949409||NOU|Continuous, Ventilator, Home Use||HEATED FLEX CABLE - ASTRAL|
Malfunction|Device Displays Incorrect Message;Temperature Problem|(B)(4).|THE
PRELIMINARY EVAL FOUND THE ROOT CAUSE TO BE THE HEATED FLEXIBLE CABLE. THE DEVICE
IS BEING SENT TO THE DESIGN FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. (B)(4).
4949410||NOU|Continuous, Ventilator, Home Use||HEATED FLEX CABLE -ASTRAL|
Malfunction|Insufficient Heating|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY EVAL WAS PERFORMED. THE EVAL
CONFIRMED THE REPORTED FAILURE AND FOUND THE ROOT CAUSE TO BE FLEXIBLE CABLE. THE
DEVICE IS BEING SENT TO THE DESIGN FACILITY IN (B)(4) FOR AN ENGINEERING
INVESTIGATION. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. (B)(4).
Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS EVALUATED BY RESMED (B)(4)
TECHNICAL SERVICE CENTER. THE EVAL DETERMINED THAT THE DEVICE FAILURE WAS DUE TO
WATER DAMAGE IN THE PNEUMATIC BLOCK AND OXYGEN SENSOR. (B)(4).
4949436|20150601|NOU|Continuous, Ventilator, Home Use||ASTRAL 150 - FUKUDA|
Malfunction|Device Displays Incorrect Message;Battery Problem|(B)(4).|THE DEVICE
WAS RECEIVED BY THE RESMED TECHNICAL SERVICES IN (B)(4) AND A PRELIMINARY EVAL WAS
PERFORMED. A REVIEW OF THE DATA LOGS CONFIRMED THAT A SYSTEM FAULT, "BATTERY
INOPERABLE" ALARM, WAS TRIGGERED IN THE DEVICE. THE DEVICE IS CURRENTLY BEING
THERE WAS NO PT HARM OR INJURY REPORTED FOR THIS INCIDENT. RESMED REF#: (B)(4).
4949455||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -EUR4|Malfunction|Failure
to Calibrate|(B)(4).|THE DEVICE WAS SENT TO THE RESMED TECHNICAL SERVICE CENTER IN
(B)(4) FOR INVESTIGATION. A REVIEW OF THE DEVICE DATA CONFIRMED THAT A SYSTEM FAULT
WAS TRIGGERED IN THE DEVICE. THE INVESTIGATION DETERMINED THAT THE RETURNED DEVICE
HAD A FAULTY NRV VALVE. THIS CAUSED THE DEVICE TO NOT COMPLETE ITS INTERNAL SELF-
TEST IN ANY VALVE CONFIGURATION. THE NRV VALVE WAS REPLACED TO ADDRESS THIS ISSUE.
ACCEPTABLE. (B)(4). NOTE: THIS COMPLAINT WAS ORIGINALLY INCORRECTLY ASSESSED AS
BEING A "NON-REPORTABLE" EVENT. DURING A ROUTINE CHECK OF COMPLAINT RECORDS THIS
WAS DETECTED. THIS REPORT IS BEING SUBMITTED TO CORRECT THE ERROR.
Battery Problem;Charging Problem|(B)(4).|THE DEVICE IS BEING RETURNED TO THE MFG
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. THERE WAS NO PT INJURY
REPORTED FOR THIS INCIDENT. (B)(4).
4949457||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 -AMER|Malfunction|Device
SERVICES IN (B)(4) AND A PRELIMINARY EVAL WAS PERFORMED. AN ANALYSIS OF THE DEVICE
LOG CONFIRMED THAT SYSTEM FAULTS WERE TRIGGERED IN THE DEVICE. THE TECHNICAL EVAL
IDENTIFIED THE ROOT CAUSE OF THE SYSTEM FAULTS AS WATER INGRESS IN THE COMPONENTS
WITHIN THE PNEUMATIC BLOCK. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT. (B)
(4).
Problem|PLEASE REFER TO IMPORTER REPORT #: (B)(4).|THE POWER SUPPLY UNIT WAS
RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND A PRELIMINARY EVAL
WAS PERFORMED. THE EVAL CONFIRMED THE PSU FAILURE AND REPLACED IT TO ADDRESS THIS
ISSUE. RESMED'S RISK ANALYSIS CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REF#:
(B)(4).
ASTRAL DEVICE WILL NOT CHARGE. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|
AN ASTRAL DEVICE DISPLAYED A "NOT DETECTING CIRCUIT" ERROR MESSAGE. THERE WAS NO PT
4949492|20150601|NOU|Continuous, Ventilator, Home Use|19793|HEATED FLEX CABLE -
ASTRAL|Malfunction|Temperature Problem;Device Displays Incorrect Message|IT WAS
REPORTED TO RESMED (B)(4) THAT DURING A SERVICE CENTER EVAL AN ASTRAL DEVICE FAILED
TO PASS ITS HEATED FLEX CABLE TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT.|
ASTRAL|Malfunction|Insufficient Heating|IT WAS REPORTED TO RESMED (B)(4) THAT THE
HEATED FLEXIBLE CABLE ON AN ASTRAL DEVICE FAILED TO HEAT PROPERLY. THERE WAS NO PT
INOPERABLE". THIS RESULTED IN AN ONGOING ALARM THAT COULDN'T BE STOPPED. THERE WAS
NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
DEVICE FAILED IT'S INTERNAL SELF-TEST. THERE WAS NO PT HARM OR INJURY REPORTED AS A
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED CORP THAT
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING A SYSTEM FAILURE. THIS
MESSAGE RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER. THERE WAS NO PT INJURY
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THERE WAS NO PT INJURY REPORTED
SERVICES IN (B)(4) AND A PRELIMINARY EVAL WAS PERFORMED. AN ANALYSIS OF THE DEVICE
LOG CONFIRMED THAT A SYSTEM FAULT (SF) 116 "INVALID AMBIENT TEMPERATURE
MEASUREMENT" ALARM WAS TRIGGERED IN THE DEVICE. THE VISUAL EVAL DETERMINED THE
SYSTEM FAULT WAS DUE TO PHYSICAL DAMAGE TO THE TEMPERATURE SENSOR WIRE. THE DEVICE
WAS REPLACED TO ADDRESS THIS ISSUE. THERE WAS NO PT INJURY REPORTED FOR THIS
INCIDENT. (B)(4).
4950218||NOU|Continuous, Ventilator, Home Use||ASTRAL 150 DEL KIT FRA|Malfunction|
Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4). THE DEVICE IS CURRENTLY BEING RETURNED TO THE MFG
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4) .
SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS
CONFIRMED THAT A SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE. THE EVAL DETERMINED
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FRACTURE OF
THE NRV ELBOW WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS
RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FRACTURE OF THE NRV ELBOW
WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE.
THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE
PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE. THE DEVICE
(B)(4).
(B)(4).
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK.
THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED,
SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
CONFIRMED THAT A SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE, INDICATING A SOFTWARE
TASK ERROR. THE EVAL DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL
SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED
TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT
WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
AN ASTRAL DEVICE DISPLAYED AN ALARM MESSAGE INDICATING A SYSTEM FAULT. THIS MESSAGE
RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER. THERE WAS NO PT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR # 3004604967-2015-00287.|
AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY. THERE WAS NO PT HARM OR INJURY REPORTED AS
A RESULT OF THIS INCIDENT. (B)(4).|
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. (B)(4).|
RESULT OF THIS INCIDENT. MFR #3004604967-2015-00291.|
DEVICE FAILED TO PASS THE INTERNAL SELF-TEST. THERE WAS NO PT INJURY REPORTED AS A
FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT INJURY REPORTED AS A RESULT
OF THIS INCIDENT. MFR # 3004604967-2015-00292.|
DEVICE FAILED TO PASS ITS INTERNAL SELF TEST. THERE ARE NO PT INJURY REPORTED AS A
DEVICE FAILED TO PASS ITS INTERNAL SELF TEST. THERE ARE NO PT INJURY REPORTED AS A
Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE MFG FACILITY IN (B)(4)
AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. ADDITIONAL INFO FROM THE
DEVICE INVESTIGATION DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO FAIL
ITS INTERNAL SELF-TEST. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS
DUE TO A LEAK ON THE NON-RETURN VALVE (NRV). THIS ISSUE WOULD NOT ALLOW THE DEVICE
TO COMPLETE ITS INTERNAL SELF-TEST. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
4964029|20150601|NOU|Continuous, Ventilator, Home Use||PSU - ASTRAL|Malfunction|
Power Problem|(B)(4).|THE POWER SUPPLY UNIT WAS RETURNED TO THE RESMED TECHNICAL
SERVICE CENTER IN (B)(4) AND A PRELIMINARY EVAL WAS PERFORMED. THE EVAL CONFIRMED
THE PSU FAILURE AND REPLACED IT TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE MFG FACILITY IN (B)(4)
AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. ADDITIONAL INFO FROM THE
DEVICE INVESTIGATION DETERMINED THAT A DEVICE MALFUNCTION CAUSED THE ASTRAL TO FAIL
ITS INTERNAL SELF-TEST. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS
DUE TO A LEAK ON THE NON-RETURN VALVE (NRV). THIS ISSUE WOULD NOT ALLOW THE DEVICE
TO COMPLETE ITS INTERNAL SELF-TEST. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT DURING THE
DISTRIBUTOR'S INCOMING INSPECTION, AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL
SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PT INVOLVEMENT.|
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THERE WAS NO PT HARM OR INJURY
Malfunction|Battery Problem;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED (B)(6) THAT AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY AND A LOW BATTERY ALARM
WAS TRIGGERED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR
LOGS CONFIRMED THAT AN UNEXPECTED RESTART OCCURRED IN THE DEVICE AND A LOW BATTERY
ALARM WAS TRIGGERED. EVALUATION SHOWED THAT THE BATTERY WAS CHARGED. EXTENSIVE
SYSTEM TESTING PERFORMED BY TECHNICAL SERVICES COULD NOT REPRODUCE THE REPORTED
ISSUE. ALL PERFORMANCE TESTING CONFIRMED THAT THE DEVICE MET SPECIFICATIONS. THE
DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED THEN RETURNED TO THE CUSTOMER.
(B)(4).
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS
EVALUATED BY RESMED (B)(4) TECHNICAL SERVICE CENTER. THE EVALUATION DETERMINED THAT
THE RETURNED DEVICE HAD A DEFECTIVE NON-RETURN VALVE (NRV) WHICH WOULD NOT ALLOW
THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST. THE NRV WAS REPLACED TO RESOLVE THE
ISSUE. (B)(4).
SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED REFERENCE#: P(B)(4).
FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PT INJURY REPORTED AS A RESULT
OF THIS INCIDENT. MFR #3004604967-2015-00305.|
Malfunction|Pressure Problem;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE HAD AN UNEXPECTED RESTART. THERE WAS NO PT
INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00306.|
Malfunction|Device Displays Incorrect Message;Failure to Calibrate|IT WAS REPORTED
TO RESMED (B)(4) THAT A SYSTEM FAULT (SF 75) OCCURRED ON AN ASTRAL DEVICE
INDICATING THE PNEUMATIC BLOCK SOFTWARE WAS NOT CALIBRATING. THERE WAS NO PT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00307.|
AN ASTRAL DEVICE TRIGGERED AN ALARM AND RESTARTED AT THE DISTRIBUTOR'S FACILITY.
INVOLVEMENT. MFR #3004604967-2015-00308.|
BATTERY, ROW|Malfunction|Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL EXTERNAL BATTERY DOES NOT CHARGE. THERE WAS NO PT HARM OR
INJURY REPORTED FOR THIS INCIDENT. MFR #3004604967-2015-00309.|
FAULT OCCURRED, THEREFORE, THERE WAS NO PT INVOLVEMENT. MFR #3004604967-2015-
00310.|
DISPLAYED INCORRECT POWER SOURCE INDICATORS WHEN THE POWER SUPPLY UNIT WAS
CONNECTED. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.
MFR #3004604967-2015-00311.|
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 ERROR MESSAGE INDICATING A SOFTWARE
MALFUNCTION. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PT INVOLVEMENT. MFR #3004604967-2015-00312.|
REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00314.|
A SYSTEM FAULT MESSAGE WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK
FAULT. THIS EVENT RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
MESSAGES. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
Displays Incorrect Message;Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO
(B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS CONFIRMED
THE CUSTOMER REPORTED LEARN CIRCUIT FAILURE. THE EVAL DETERMINED THAT THE DEVICE
Displays Incorrect Message;Pressure Problem;Inappropriate or Unexpected Reset|(B)
(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL
WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOGS CONFIRMED THE DEVICE RESTARTED
AFTER AN OVERPRESSURE EVENT. THE EVAL FOUND THE DEVICE HAD A FAULTY MAIN CIRCUIT
BOARD (PCB). THE PCB WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED,
to Calibrate;Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RETURNED TO
THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE
DEVICE DATA CONFIRMED THAT A SYSTEM FAULT 75 WAS TRIGGERED IN THE DEVICE. THE EVAL
DETERMINED THAT THE SYSTEM FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED,
Malfunction|Inappropriate or Unexpected Reset|(B)(4).|THE DEVICE WAS RETURNED TO
THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF THE
DOWNLOADED ERROR LOGS CONFIRMED THAT AN ALARM WAS TRIGGERED AND THE DEVICE
RESTARTED. THE SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICE STAFF COULD NOT
REPRODUCE THE REPORTED FAULTS. THE EVAL RESULTED IN "NO FAULT FOUND". THE DEVICE
WAS CLEANED, SERVICED, CALIBRATED AND TESTED BEFORE RETURNING TO THE CUSTOMER.
(B)(4).
Malfunction|Battery Problem;Charging Problem|(B)(4).|RESMED (B)(4) WAS INFORMED
THAT THE EXTERNAL BATTERY WOULD BE RETURNED FOR EVAL. THE PRODUCT HAS NOT YET BEEN
RECEIVED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AS THIS
TIME. (B)(4).
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO (B)(4) AND AN EVAL WAS PERFORMED. A
REVIEW OF THE DOWNLOADED ERROR LOGS CONFIRMED THE CUSTOMER REPORTED CIRCUIT TEST
FAILURE. THE EVAL DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A DEFECTIVE
(B)(4).
Problem|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN
(B)(4) FOR INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE
CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE.
THE SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES STAFF COULD NOT REPRODUCE
THE FAULT. THE EVAL SHOWED THAT THE DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-
TEST. THIS FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED
BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO COMPLETE ITS INTERNAL SELF-
TEST WAS DUE TO A BROKEN NON-RETURN VALVE (NRV) IN THE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED,
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN
(B)(4) AND AN EVAL WAS PERFORMED. THE EVAL DETERMINED THAT THE DEVICE FAILURE WAS
DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE
THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED
TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN
(B)(4) AND AN EVAL WAS PERFORMED. THE EVAL DETERMINED THAT THE DEVICE FAILURE WAS
DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE
THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, AND CALIBRATED BEFORE IT WAS RETURNED
Malfunction|Device Displays Incorrect Message|(B)(4).|THE DEVICE WAS RECEIVED BY
RESMED TECHNICAL SERVICES IN (B)(4). THE DEVICE WAS RETURNED TO THE (B)(4) IN (B)
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED DATA
CONFIRMED THAT A TECHNICAL ALARM WAS TRIGGERED IN THE DEVICE. THE INVESTIGATION
DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE WAS A FAULTY PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED,
SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S
(4). NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS
ASSESSED AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF
THIS COMPLAINT REPORT AS WELL AS THE DEVICE INVESTIGATION IDENTIFIED INFORMATION TO
CHANGE THE ASSESSMENT TO REPORTABLE.
4994518||NOU|Continuous, Ventilator, Home Use||ASTRAL 100 SGL KIT - EUR4|
Malfunction|Failure to Calibrate|IMPORTER REF# (B)(4).|THE DEVICE WAS RETURNED TO
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE
INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC
BLOCK. THIS ISSUE WOULD NOT ALLOW THE DEVICE TO COMPLETE ITS BLOWER TEST. RESMED'S
ASSESSED AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF
THIS COMPLAINT REPORT AS WELL AS THE DEVICE INVESTIGATION IDENTIFIED INFORMATION TO
to Calibrate|IMPORTER REF# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE INVESTIGATION
DETERMINED THAT THE REPORTED FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THIS
ISSUE WOULD NOT ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST. THE PNEUMATICF
BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED,
CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED
AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF THIS
COMPLAINT REPORT AS WELL AS THE DEVICE INVESTIGATION IDENTIFIED INFORMATION TO
Failure to Calibrate|IMP REF# (B)(4).|THE DEVICE WAS RETURNED TO THE MANUFACTURING
FACILITY IN (B)(4) AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. THE
INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC
BLOCK. THIS ISSUE WOULD NOT ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST.
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED,
NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED
AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF THIS
to Calibrate|IMP REF# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
THAT THE REPORTED FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THIS ISSUE WOULD
NOT ALLOW THE DEVICE TO COMPLETE A PORTION OF ITS INTERNAL SELF-TEST. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED,
to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
REPORTED FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THIS ISSUE WOULD NOT ALLOW
THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST. DURING EVALUATION, IT WAS ALSO
DISCOVERED THAT THE DEVICE TRIGGERED A SYSTEM FAULT (SF) 116 ERROR MESSAGE. THE
EVALUATION WAS NOT ABLE TO REPRODUCE THE IDENTIFIED FAULT. RESMED'S RISK ANALYSIS
FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Failure to Calibrate|IMPORTER REF# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAILED ITS INTERNAL SELF-TEST. THE DEVICE IS CURRENTLY
to Calibrate|IMPORTER REF# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
THAT THE REPORTED DEVICE FAILURE WAS DUE TO WATER CONTAMINATION. THIS ISSUE WOULD
NOT ALLOW THE DEVICE TO COMPLETE ITS INTERNAL SELF-TEST. DURING EVALUATION, IT WAS
ALSO DISCOVERED THAT THE DEVICE TRIGGERED SYSTEM FAULTS (SF) 188 AND 218. THE
EVALUATION WAS NOT ABLE TO REPRODUCE THE IDENTIFIED FAULTS. RESMED'S RISK ANALYSIS
GENERAL SERVICE AND EVALUATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|
EUR 4|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE FAILED TO PASS ITS BLOWER TEST. THERE WAS NO PATIENT INJURY REPORTED
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(6) THAT DURING
TECHNICAL INSPECTION AN ASTRAL DEVICE FAILED A PORTION OF ITS INTERNAL SELF-TEST.
INVOLVEMENT.|
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE "INTERNAL BATTERY INOPERABLE." THIS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO
THE MANUFACTURING FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION. THE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 (SF 74) MESSAGE INDICATING A SOFTWARE
TASK ERROR. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR AN
INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSIONS ARE NOT
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGE 219. THIS RESULTED IN AN ALARM WHICH
NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICE CENTER IN (B)(4) FOR AN INVESTIGATION. THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSIONS ARE NOT FINALIZED AT THIS STAGE. (B)(4).
CUSTOMER. (B)(4).
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED CORP. THAT AN
ASTRAL DEVICE DISPLAYED AN ALARM (SF 101) INDICATING THAT THE OUTLET PRESSURE
MEASUREMENT MAY BE INCORRECT. PER THE REPORTER, THE PATIENT HAD TO BE MANUALLY
VENTILATED WHILE ANOTHER MACHINE WAS SET UP. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO (B)(4) FOR AN EVALUATION.
AN ANALYSIS OF THE DEVICE LOG CONFIRMED THAT A SYSTEM FAULT 101 WAS TRIGGERED IN
THE DEVICE. IT WAS ALSO FOUND THAT SYSTEM FAULT 74 WAS TRIGGERED IN THE DEVICE
INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE IS CURRENTLY BEING RETURNED
TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN ENGINEERING INVESTIGATION.
(B)(4).
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT WHILE SERVICING THE
DEVICE THE ASTRAL INTERNAL BATTERY WILL NOT HOLD A CHARGE. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|RESMED
HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION
COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS
UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
Malfunction|Battery Problem;Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(6)
THAT AN ASTRAL DEVICE HAD A DEFECTIVE BATTERY AND FAILED TO PASS ITS INTERNAL SELF-
TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE EVALUATION ALSO
DETERMINED THAT THE DEVICE HAD A DEFECTIVE INTERNAL BATTERY. TO ADDRESS THIS ISSUE,
THE PNEUMATIC BLOCK AND INTERNAL BATTERY WERE BOTH REPLACED. THE DEVICE WAS
CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
ACCEPTABLE. (B)(4).
ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(6) THAN
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES INDICATING A SELF-TEST FAILURE. THERE WAS
REPORTED ISSUE OF THE SELF-TEST FAILURE COULD NOT BE REPRODUCED, HOWEVER THE
EVALUATION DETERMINED THE DEVICE HAD A DEFECTIVE TOP CASE. THE TOP CASE WAS
REPLACED AND THE DEVICE SOFTWARE WAS UPDATED TO ADDRESS THE ISSUES. RESMED'S RISK
Problem|(B)(4).|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER
LOCATED IN BREMEN, GERMANY FOR EVALUATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE#: (B)(4).
Failure to Calibrate|(B)(4).|THE DEVICE WAS RETURNED TO (B)(4) AND AN EVALUATION
WAS PERFORMED. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE WAS DUE TO A
FAULTY NON-RETURN VALVE (NRV). THE NRV WAS REPLACED TO ADDRESS THIS ISSUE. THE
DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. AN
IN-DEPTH ANALYSIS OF THIS COMPLAINT REPORT WAS WELL AS THE DEVICE INVESTIGATION
IDENTIFIED INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
Failure to Calibrate|IMP# (B)(4).|THE DEVICE WAS RETURNED TO RESMED TECHNICAL
SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. DURING THE EVALUATION, IT
WAS FOUND THAT THE FLOW SENSOR WAS OUT OF CALIBRATION. THE PNEUMATIC BLOCK WAS
REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND
TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS
COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-
REPORTABLE LIFE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF THIS COMPLAINT REPORT AS
WELL AS THE DEVICE INVESTIGATION IDENTIFIED INFORMATION TO CHANGE THE ASSESSMENT TO
REPORTABLE.
Device Displays Incorrect Message;Battery Problem|IMP# (B)(4).|THE DEVICE WAS
RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS
PERFORMED. A REVIEW OF THE DATA LOGS CONFIRMED THAT A SYSTEM FAULT, "BATTERY
INOPERABLE" ALARM, WAS TRIGGERED IN THE DEVICE. THE DEVICE IS CURRENTLY BEING
RETURNED TO THE MANUFACTURING FACILITY LOCATED IN SYDNEY, AUSTRALIA FOR AN
Battery Problem;Device Displays Incorrect Message|IMP# (B)(4).|THE DEVICE WAS
Calibration Problem|IMP# (B)(4).|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICE CENTER IN (B)(4) AND AN EVAL WAS PERFORMED. THE EVAL FOUND THE DEVICE TO BE
OUT OF CALIBRATION. TO ADDRESS THIS ISSUE, THE DEVICE WAS RE-CALIBRATED AND
RETURNED TO THE CUSTOMER. (B)(4).
HAD A POWER FAILURE AFTER USING THE EXTERNAL POWER SUPPLY. THERE WAS NO PATIENT
HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00317.|
DEVICE WOULD NOT ACCEPT USER SETTINGS IN A SINGLE LIMB CIRCUIT SET-UP. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00320.|
GENERAL SERVICE AND EVALUATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
Device Displays Incorrect Message|IMP # (B)(4).|THE DEVICE WAS RETURNED TO THE
RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVAL WAS PERFORMED. A REVIEW OF
THE DOWNLOADED ERROR LOGS CONFIRMED THAT SYSTEM FAULTS 197 AND 218 WERE TRIGGERED
IN THE DEVICE. THE EVAL DETERMINED THAT THE REPORTED SYSTEM FAULTS WERE DUE TO
WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK. (B)(4).
INOPERABLE". THIS RESULTED IN AN ONGOING ALARM THAT COULDN'T BE STOPPED. THE DEVICE
INVOLVEMENT. MFR# 3004604967-2015-00325.|
INOPERABLE". THIS RESULTED IN AN ONGOING ALARM THAT COULDN'T BE STOPPED. THERE WAS
NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS. INCIDENT. MFR# 3004604967-
2015-00326.|
Malfunction|Calibration Problem|IT WAS REPORTED TO RESMED (B)(6) THAT THE POSITIVE
END EXPIRATORY PRESSURE (PEEP) READINGS ON AN ASTRAL DEVICE WERE BEYOND ITS
SCRIPTED LIMITS. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR
#3004604967-2015-00329.|
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES INDICATING A FLOW SENSOR ISSUE. THIS
NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED LTD THAT A
SYSTEM FAULT (SF101) WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET
PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN (B)(4) FOR INVESTIGATION. THE INVESTIGATION WAS UNABLE TO REPLICATE THE
FAULT UNDER NORMAL USE CONDITIONS. THE DEVICE PERFORMED TO SPECIFICATIONS IN ALL
ASPECTS. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS
INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A LEAKY NON-RETURN VALVE (NRV) WITHIN THE PNEUMATIC
BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE MALFUNCTION EVENT. AN IN-
DEPTH ANALYSIS OF THIS COMPLAINT REPORT AS WELL AS THE DEVICE INVESTIGATION
IDENTIFIED INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO
EVALUATION DETERMINED THAT THE DEVICE RESTART WAS DUE TO A DEFECTIVE PNEUMATIC
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THIS ISSUE. RESMED'S RISK
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE TRIGGERED AN ALARM AND
RESTARTED UNEXPECTEDLY AT THE DISTRIBUTOR'S FACILITY. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE
WAS RECEIVED BY (B)(4) AND IT IS CURRENTLY BEING SENT TO (B)(4) FOR INVESTIGATION.
(B)(4).
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO (B)(4) AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 ERROR MESSAGE INDICATING A SOFTWARE
MALFUNCTION. THERE WAS NO PT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #
3004604967-2015-00256.|
INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A FRACTURE IN THE NON-RETURN VALVE (NRV) ELBOW.
(B)(4). NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS
ASSESSED AS BEING A NON-REPORTABLE MALFUNCTION EVENT. AN IN-DEPTH ANALYSIS OF THIS
Malfunction|Device Inoperable;Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT
DURING INCOMING INSPECTION, AN ASTRAL DEVICE HAD A POWER FAILURE AND BECAME
INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN SYDNEY, AUSTRALIA FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS, AND CONCLUSIONS ARE NOT FINALIZED AT THIS STAGE. (B)(4).
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE TRIGGERED A LOW BATTERY ALARM
AND RESTARTED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED DATA SHOWED THAT A SYSTEM
FAULT "LOW BATTERY" ALARM WAS TRIGGERED IN THE DEVICE CAUSING IT TO RESTART. THE
EVALUATION DETERMINED THAT THE ALARMS WERE TRIGGERED CORRECTLY INDICATING THE
INTERNAL BATTERY NEEDED TO BE RECHARGED. FURTHER TECHNICAL SERVICE EVALUATION
DETECTED A SELF-TEST FAILURE. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message;Power Problem|IT WAS REPORTED BY
RESMED (B)(4) THAT AN ASTRAL DEVICE'S BATTERY ALARM WAS TRIGGERED RESULTING IN A
POWER MANAGEMENT PROBLEM. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4).
THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED'S TECHNICAL SERVICE
CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE
TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS CLEANED,
SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED'S TECHNICAL SERVICE
CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE
PNEUMATIC BLOCK WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS CLEANED,
Malfunction|Power Problem;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED (B)(6) THAT A SYSTEM FAULT (SF218) OCCURRED ON AN ASTRAL DEVICE WHICH
RESULTED IN AN ALARM NOTIFYING THE USER OF THE ERROR MESSAGE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED
TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. REVIEW OF THE
DOWNLOADED DEVICE LOG SHOWED THAT ERROR MESSAGES SF218 AND SF180 (BATTERY CHARGER
FAULT) WERE TRIGGERED IN THE DEVICE. THE EVALUATION SHOWED THAT THE DEVICE AND
BATTERY PASSED SERVICE TESTING REQUIREMENTS. THE DEVICE WAS CLEANED, SERVICED,
CALIBRATED AND TESTED THEN RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL DEVICE
HAD A BATTERY FAULT RESULTING IN AN AUDIBLE ALARM. THERE WAS NO PATIENT HARM OR
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE
(4).
REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Malfunction|Insufficient Heating|IT WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL
DEVICE FAILED TO PASS ITS HEATED FLEX CABLE TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO PASS ITS HEATED
FLEX CABLE TEST WAS DUE TO A DEFECTIVE HEATING ELEMENT. THE HEATED FLEX CABLE WAS
INTERNAL SELF-TEST WAS DUE TO A DRIFTING FLOW SENSOR. THE PNEUMATIC BLOCK WAS
A SYSTEM FAULT (SF 223) WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A POSITIVE END
EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR
LOGS CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 223 WAS TRIGGERED IN THE
DEVICE. FURTHER TECHNICAL SERVICE EVALUATION DETECTED AN IN HOUSE SELF-TEST
FAILURE. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK
ASTRAL DEVICE PROMPTED A RED SCREEN WITH A SYSTEM FAULT ERROR MESSAGE "RETURN FOR
SERVICE." THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. A PRELIMINARY INSPECTION REVEALED
EXTERIOR DAMAGE TO THE UNIT POSSIBLY CAUSED BY THE ASTRAL DEVICE BEING DROPPED BY
THE PATIENT OR CAREGIVER. THE DEVICE IS CURRENTLY BEING RETURNED TO THE
(4).
TO RESMED THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST AND TRIGGERED
AN "INCORRECT-CIRCUIT" ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A
DEFECTIVE EXPIRATORY FLOW SENSOR. THE EXPIRATORY FLOW SENSOR AND AIR INLET FILTER
WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
A SYSTEM FAULT (SF 180) OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER
FAULT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE REPORTER OF THE ERROR MESSAGE.
INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE (B)(6) CENTER IN (B)(6) AND AN
EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED ERROR LOG CONFIRMED THAT A
SYSTEM FAULT 180 WAS TRIGGERED IN THE DEVICE. FURTHER TECHNICAL SERVICE EVALUATION
DETECTED A SELF-TEST FAILURE CAUSED BY A LEAK IN THE PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED, AND THE DEVICE WAS SERVICED TO ADDRESS THESE ISSUES. RESMED'S
RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED
REFERENCE #: (B)(4).
DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NOT PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE (B)(6) CENTER IN (B)
(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)
(4).
TO RESMED (B)(4) THAT A SYSTEM FAULT (SF 223) WAS OBSERVED ON AN ASTRAL DEVICE
INDICATING A POSITIVE END EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE. THE ASTRAL
DEVICE WAS UNABLE TO PASS ITS INTERNAL SELF-TEST AFTER THE SYSTEM FAULT WAS
OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 223 AND
FAILED INTERNAL SELF-TEST WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE
FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Circuit Failure|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE
HAD A DEFECTIVE FLOW SENSOR AND CIRCUIT CONNECTION. THE DEVICE WAS NOT IN USE WHEN
RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN PARIS, FRANCE AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE CIRCUIT AND FLOW SENSOR
FAILURE WAS DUE TO PHYSICAL DAMAGE TO THE DEVICE. RESMED'S RISK ANALYSIS FOR THESE
FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
RESMED THAT A CUSTOMER HAD AN ASTRAL DEVICE WITH A "BATTERY INOPERABLE" ALARM. THIS
RESULTED IN A TOTAL POWER FAILURE OF THE DEVICE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER
IN (B)(6) FOR EVALUATION AND WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN
SYDNEY, AUSTRALIA FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE
#: (B)(4).
DISPLAY SCREEN WAS FLICKERING, AND THE DEVICE WAS INOPERABLE. THERE WAS NO PATIENT
HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION AND WAS RETURNED TO
THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF74) OCCURRED ON AN ASTRAL
DEVICE INDICATING A SOFTWARE TASK ERROR. THIS CAUSED THE ASTRAL DEVICE TO RESTART
UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND COULD NOT BE
REPRODUCED DURING IN-HOUSE SYSTEM TESTING. FURTHER EVALUATION DETECTED A LEAK TEST
FAILURE DURING DEVICE CALIBRATION. THE PNEUMATIC BLOCK AND MAIN CIRCUIT BOARD (PCB)
WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
Malfunction|Charging Problem|IT WAS REPORTED BY A RESMED PRODUCT MANAGER THAT AN
ASTRAL DEVICE WILL NOT HOLD A CHARGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION
DETERMINED THAT THE DEVICE CHARGING FAILURE WAS DUE TO A DEFECTIVE INTERNAL
BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S
ASTRAL|Malfunction|Insufficient Heating|IT WAS REPORTED TO RESMED FRANCE THAT AN
ASTRAL DEVICE FAILED TO PASS ITS HEATED FLEX CABLE TEST. THE DEVICE WAS NOT IN USE
WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS HEATED
FLEX CABLE TEST WAS DUE TO A DEFECTIVE HEATING ELEMENT. RESMED'S RISK ANALYSIS FOR
WAS REPORTED TO RESMED (B)(4)THAT SYSTEM FAULT MESSAGES WERE OBSERVED ON AN ASTRAL
DEVICE INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THIS
RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGES AND DEVICE
RESTART. THE CAREGIVER PLACED THE PATIENT ON A BACK-UP VENTILATOR. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION AND IS CURRENTLY BEING
RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE
WAS NOT DETECTING THE CORRECT POWER SOURCE. THIS POWER FAULT RESULTED IN THE DEVICE
GENERATING AN AUDIBLE ALARM THAT NOTIFIED THE USER OF THE MALFUNCTION. THERE WAS NO
ENTERED "AUTO POWER-OFF MODE" AND POWERED DOWN. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAILURE WAS A SINGLE OCCURRENCE AND COULD NOT BE
REPRODUCED DURING IN-HOUSE SYSTEM TESTING. THE "AUTO POWER OFF" FEATURE POWERS OFF
THE DEVICE WHEN THERE HAS BEEN NO INTERACTION WITH THE DEVICE FOR 15 MINUTES, IT IS
USING AN EXTERNAL BATTERY, AND THE VENTILATOR IS IN STAND-BY MODE. THE POWER
FAILURE WAS TRIGGERED APPROPRIATELY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
MAIN CIRCUIT BOARD (PCB). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
THAT WHILE SETTING UP AN ASTRAL DEVICE, THE SCREEN WAS BLACK AND AN AUDIBLE ALARM
WAS TRIGGERED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6)
FOR EVALUATION AND WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(6) FOR
AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 150) ERROR MESSAGE INDICATING A
HARDWARE ISSUE. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE REPORTER OF THE ERROR
MESSAGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED HAS REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING
INVESTIGATION COULD BE PERFORMED. SINCE THE DEVICE HAS NOT YET BEEN RETURNED,
RESMED IS UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE THE CAUSE OF THE MALFUNCTION
AT THIS TIME. RESMED REFERENCE #: (B)(4).
Malfunction|Power Problem;Failure to Calibrate;Device Displays Incorrect Message|IT
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE.
THIS RESULTED IN A TOTAL POWER FAILURE (TPF) OF THE DEVICE FOLLOWED BY AN
UNEXPECTED RESTART. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
Malfunction|Failure to Calibrate;Inappropriate or Unexpected Reset|IT WAS REPORTED
TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST AND
UNEXPECTEDLY RESTARTED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO PASS ITS
INTERNAL SELF-TEST WAS DUE TO THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS SERVICED
TO ADDRESS THIS ISSUE. THE UNEXPECTED RESTART EVENT OCCURRED AS EXPECTED WHEN THE
BATTERY WAS COMPLETELY DISCHARGED. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
REPORTED TO RESMED THAT DURING THERAPY, AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES
INDICATING THAT THE VENTILATION HAD STOPPED. THESE MESSAGES RESULTED IN AN AUDIBLE
ALARM THAT NOTIFIED THE PATIENT AND CAREGIVER. THE PATIENT WAS MANUALLY VENTILATED
BEFORE A BACK UP DEVICE COULD BE SET-UP. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY (B)(4)FOR EVALUATION AND WAS
DEVICE'S BATTERY WAS DEFECTIVE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE BATTERY
DEFECT WAS DUE TO A FAULTY INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF
74) INDICATING A SOFTWARE TASK ERROR. THIS RESULTED IN AN AUDIBLE ALARM AND
UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|RESMED HAS REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING
FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM OR INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL
SERVICE CENTER IN (B)(4) FOR EVALUATION AND WAS RETURNED TO THE MANUFACTURING
FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
DEVICE WAS UNABLE TO PASS ITS CALIBRATION TEST. THE DEVICE WAS NOT IN USE WHEN THE
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO PASS ITS
CALIBRATION TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
A SYSTEM FAULT (SF 180) OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER
FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RECEIVED BY THE RESMED (B)(4) AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE DEVICE SYSTEM FAULT 180 WAS TRIGGERED DUE TO A
SOFTWARE TIMING ISSUE WITHIN THE MAIN CIRCUIT BOARD (PCB). FURTHER TECHNICAL
EVALUATION FOUND AN ELECTRICAL FAULT ON THE MAIN PCB. THE DEVICE WAS SERVICED TO
ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT
THE RISK IS ACCEPTABLE. (B)(4).
ASTRAL|Malfunction|Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE'S BATTERY WAS DEFECTIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED
TECHNICAL SERVICE CENTER IN (B)(4), FOR EVALUATION AND WAS RETURNED TO THE
MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED FRANCE THAT AN ASTRAL
DEVICE'S BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN
(B)(4) FOR EVALUATION AND WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)
(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS,
AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).
RESMED (B)(6) THAT AN ASTRAL DEVICE'S INTERNAL BATTERY WAS INOPERABLE. THIS
NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS
RESMED (B)(4) THAT AN ASTRAL DEVICE'S INTERNAL BATTERY WAS INOPERABLE. THIS
NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS
REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING INVESTIGATION COULD BE
PERFORMED. SINCE THE DEVICE HAS NOT YET BEEN RETURNED, RESMED IS UNABLE TO CONFIRM
THE COMPLAINT OR DETERMINE THE CAUSE OF THE MALFUNCTION AT THIS TIME. (B)(4).
RESMED JAPAN THAT AN ASTRAL DEVICE'S INTERNAL BATTERY WAS INOPERABLE. THIS RESULTED
IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT
HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED THE
DEVICE BE RETURNED SO AN ENGINEERING INVESTIGATION COULD BE PERFORMED. SINCE THE
DEVICE HAS NOT YET BEEN RETURNED, RESMED IS UNABLE TO CONFIRM THE COMPLAINT OR
DETERMINE THE CAUSE OF THE MALFUNCTION AT THIS TIME. (B)(4).
Malfunction|Device Inoperable;Incorrect Measurement|IT WAS REPORTED TO RESMED THAT
AN ASTRAL DEVICE'S TOUCHSCREEN DISPLAY WAS NOT RESPONDING AND THE OXYGEN ANALYZER
WAS MALFUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4)
FOR EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED
POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE RESMED TECHNICAL SERVICE CENTER IN PARIS, FRANCE FOR EVALUATION. THE EVALUATION
5051855|20150629|NOU|Continuous, Ventilator, Home Use|19600|MAIN PCB - ASTRAL 150|
DEVICE'S TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS EVALUATED BY A RESMED DISTRIBUTOR IN (B)
(4). THE EVALUATION DETERMINED THAT THE SCREEN FAILURE WAS DUE TO A DEFECTIVE MAIN
CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 74) INDICATING A SOFTWARE TASK
ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS EVALUATED BY A RESMED DISTRIBUTOR IN (B)(4). THE EVALUATION DETERMINED
THAT THE SYSTEM FAULT 74 WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN
PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
TO RESMED (B)(6) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 74)
INDICATING A SOFTWARE TASK ERROR. THE DEVICE ALSO FAILED TO PASS ITS INTERNAL SELF-
WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS DUE TO A
DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ISSUE. FURTHER EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECIEVED BY THE RESMED TECHNICAL
REFERENCE: (B)(4).
Malfunction|Device Sensing Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE'S ALARM MUTE / RESET BUTTON WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY
DEVICE MALFUNCTION WAS DUE TO AN ELECTRONIC COMPONENT FAILURE WITHIN THE TOP CASE
ASSEMBLY. THE TOP CASE WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #:
(B)(4).
Device Alarm System|AUTHORIZED SERVICE CENTER IN (B)(6) REPORTED THAT DEVICE FAILED
WITH ERROR CODE 9.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO
INSUFFICIENT PATIENT INFORMATION. BASED UPON THE INFORMATION THAT BREAS PRESENTLY
POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE UNDER THE
STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS AND GUIDANCE. ACCORDINGLY, IN
AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT. BEING
PART OF A RETROSPECTIVE ANALYSIS, THIS REPORT IS SUBMITTED LATER THAN 30 DAYS AFTER
THE INITIAL DATE ON WHICH BREAS BECAME AWARE OF THE EVENT, AS HAS PREVIOUSLY BEEN
DISCUSSED WITH THE FDA.
Device Displays Incorrect Message|DISTRIBUTOR IN (B)(6) REPORTS A DEVICE EXHIBITING
AN INTERNAL FUNCTION FAILURE WITH CODE # 55. THE CPU BOARD WAS REPLACED TO RECTIFY
THE PROBLEM. THE DEFECTIVE BOARD WAS SENT TO BREAS HQ FOR ANALYSIS.|THIS MEDWATCH
REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS
BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON THE
INFORMATION THAT BREAS PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE
EVENT IS REPORTABLE UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS
AND GUIDANCE. ACCORDINGLY, IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH
REPORT FOR THIS EVENT. BEING PART OF A RETROSPECTIVE ANALYSIS, THIS REPORT IS
SUBMITTED LATER THAN 30 DAYS AFTER THE INITIAL DATE ON WHICH BREAS BECAME AWARE OF
THE EVENT, AS HAS PREVIOUSLY BEEN DISCUSSED WITH THE FDA.
Failure to Power Up|DISTRIBUTOR IN (B)(4) REPORTS A DEVICE HAVING A STRONG SMELL
OF BURNT ELECTRONIC MATERIALS AND WITH A BLANK SCREEN. THE DEFECTIVE DEVICE WAS
SENT TO BREAS HQ FOR ANALYSIS.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH
Device Displays Incorrect Message|BREAS (B)(4) SERVICE CENTER REPORTED THAT A VIVO
50 SHOWED ERROR CODE 39 - THE BLOWER DOES NOT FUNCTION PROPERLY.|UNDER EUROPEAN
LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE
HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF
CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT
INFORMATION. BASED UPON THE INFORMATION THAT BREAS PRESENTLY POSSESSES, IT IS
UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE UNDER THE STANDARD SET FORTH IN
THE APPLICABLE FDA REGULATIONS AND GUIDANCE. ACCORDINGLY, IN AN ABUNDANCE OF
CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT. BEING PART OF A
RETROSPECTIVE ANALYSIS, THIS REPORT IS SUBMITTED LATER THAN 30 DAYS AFTER THE
INITIAL DATE ON WHICH BREAS BECAME AWARE OF THE EVENT, AS HAS PREVIOUSLY BEEN
DISCUSSED WITH THE FDA. NOT RETURNED TO MANUFACTURER
Battery Problem|BREAS (B)(4) SERVICE CENTER REPORTED THAT AN INTERNAL BATTERY TO A
VIVO 50 WAS MALFUNCTIONING. THE VIVO 50 DID NOT DETECT THE BATTERY. THE BATTERY WAS
REPLACED TO RECTIFY THE PROBLEM.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
Device Displays Incorrect Message|AUTHORIZED SERVICE TECHNICIAN REPORTED THAT THE
DEVICE HAS SHOWN ERROR 39 - THE BLOWER DOES NOT FUNCTION PROPERLY. THE PSU-BOARD
WAS FOUND FAULTY ACCORDING TO THE REPORT.|UNDER EUROPEAN LAW, PATIENT INFORMATION
IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH
Device Displays Incorrect Message|BREAS (B)(4) SERVICE CENTER REPORTED THAT DEVICE
SHOWED ERROR 18 - 5 V OR 12 V ON PSU BOARD IS OUT OF RANGE. THE DEVICE WAS
INVESTIGATED AT THE (B)(4) OFFICE AND THE PSU-BOARD WAS FOUND FAULTY.|UNDER
EUROPEAN LAW, PATIENT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY
THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF
RESMED (B)(4) THAT AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY AND A BATTERY INOPERABLE
ALARM WAS TRIGGERED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL
SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE
DOWNLOADED ERROR LOGS CONFIRMED THAT AN UNEXPECTED RESTART OCCURRED IN THE DEVICE
AND A BATTERY INOPERABLE ALARM WAS TRIGGERED. EVALUATION SHOWED THAT THE DEVICE
BATTERY WAS COMPLETELY DISCHARGED. THE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
THE DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED THEN RETURNED TO THE
CUSTOMER. (B)(4).
AN ASTRAL DEVICE DISPLAYED AN "ERROR SYSTEM 116" MESSAGE INDICATING AN INVALID
AMBIENT TEMPERATURE. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE
ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE ASTRAL DEVICE WAS RETURNED TO RESMED (B)(4) TECHNICAL SERVICE CENTER AND AN
EVALUATION WAS PERFORMED. THE RETURNED DEVICE EVALUATION DETERMINED THAT THE
REPORTED ISSUE WAS DUE A DISCONNECTED THERMISTOR CABLE. THE THERMISTOR CABLE WAS
RE-ASSEMBLED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED
AND TESTED THEN RETURNED TO THE CUSTOMER. (B)(4).
Device Inoperable;Device Operational Issue|BREAS SERVICE CENTER IN (B)(4) REPORTED
A DEVICE SHOWING ERROR CODE #39 OCH INTERMITTENT ERROR CODE #18.|UNDER (B)(4) LAW,
PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE
Device Inoperable;Device Operational Issue|BREAS AUTHORIZED DISTRIBUTOR IN (B)(4)
REPORTED A DEVICE SHOWING ERROR CODE #18.|UNDER (B)(4) LAW, PATIENT INFORMATION IS
Device Operational Issue;Device Inoperable|BREAS AUTHORIZED DISTRIBUTOR IN (B)(6)
REPORTED A DEVICE SHOWING ERROR CODE #35.|UNDER EUROPEAN LAW, PATIENT INFORMATION
Device Inoperable;Device Operational Issue|BREAS DISTRIBUTOR IN (B)(4) REPORTED A
DEVICE SHOWING ERROR CODE #55.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Device Operational Issue;Device Inoperable|BREAS SERVICE CENTER IN (B)(4) REPORTED
A DEVICE SHOWING ERROR CODE #21.|UNDER (B)(4) LAW, PATIENT INFORMATION IS
Device Displays Incorrect Message|SERVICE CENTER IN (B)(4) REPORTED THAT THE UNIT
HAS SHOWN ERROR CODE 30 INDICATING THAT MAIN AND BACK-UP PRESSURE SENSORS DOES NOT
MATCH. THE PTU-BLOCK WAS REPLACED TO RECTIFY THE PROBLEM.|UNDER (B)(4) LAW, PATIENT
THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER
COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION.
BASED UPON THE INFORMATION THAT BREAS PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM
WHETHER THE EVENT IS REPORTABLE UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA
REGULATIONS AND GUIDANCE. ACCORDINGLY, IN AN ABUNDANCE OF CAUTION, BREAS IS FILING
A MEDWATCH REPORT FOR THIS EVENT. BEING PART OF A RETROSPECTIVE ANALYSIS, THIS
REPORT IS SUBMITTED LATER THAN 30 DAYS AFTER THE INITIAL DATE ON WHICH BREAS BECAME
AWARE OF THE EVENT, AS HAS PREVIOUSLY BEEN DISCUSSED WITH THE FDA.
Battery Problem|SERVICE CENTER IN (B)(4) REPORTED THAT THE INTERNAL BATTERY OF THE
DEVICE COULD NOT STORE THE POWER. THEY COULD ONLY USE THE DEVICE ON INTERNAL
BATTERY FOR 30 MINUTES.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE THE
ASTRAL DEVICE WAS BEING CONFIGURED FOR A PATIENT, IT FAILED TO PASS ITS CALIBRATION
WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION AND
WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT WHILE THE ASTRAL
DEVICE WAS BEING CONFIGURED FOR A PATIENT, THE DISPLAY SCREEN WENT BLACK AND AN
AUDIBLE ALARM SOUNDED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS EVALUATED BY A RESMED DISTRIBUTOR IN THE UNITED STATES.
THE EVALUATION DETERMINED THAT THE SCREEN FAILURE WAS NOT REPRODUCIBLE AND THERE
WAS NO FAULT FOUND ON THE DEVICE. THE DEVICE WAS SERVICED AND PERFORMED TO
SPECIFICATIONS. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR
EVALUATION. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS DUE TO A
DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Malfunction|Device Difficult to Program or Calibrate|IT WAS REPORTED TO RESMED THAT
WHILE A CLINICIAN WAS SETTING UP AN ASTRAL, THE DEVICE FAILED TO SAVE THE
PROGRAMMED PATIENT SETTINGS AND REVERTED BACK TO THE DEFAULT SETTINGS. THERE WAS NO
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION WAS
UNABLE TO CONFIRM THE REPORTED ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Device Inoperable|BREAS SERVICE CENTER IN (B)(6) REPORTED A DEVICE SHOWING ERROR
CODES #37 AND #39.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL
AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A
RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE
DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON THE INFORMATION THAT BREAS
PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE UNDER
THE STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS AND GUIDANCE. ACCORDINGLY,
IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT. BEING
Device Inoperable|(B)(6) DISTRIBUTOR REPORTED A DEVICE SHOWING ERROR CODE #39.|
UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE
RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Battery Problem|DISTRIBUTOR IN (B)(6) REPORTS A DEVICE WITH AN INTERNAL BATTERY NOT
CHARGING, ONLY WORKS WITH MAINS POWER CONNECTION.|THIS MEDWATCH REPORT IS A RESULT
OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED
REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON THE INFORMATION THAT
BREAS PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE
UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS AND GUIDANCE.
ACCORDINGLY, IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS
EVENT. BEING PART OF A RETROSPECTIVE ANALYSIS, THIS REPORT IS SUBMITTED LATER THAN
30 DAYS AFTER THE INITIAL DATE ON WHICH BREAS BECAME AWARE OF THE EVENT, AS HAS
PREVIOUSLY BEEN DISCUSSED WITH THE FDA.
Device Displays Incorrect Message|HOSPITAL IN THE (B)(6) REPORTED THAT THE UNIT HAS
SHOWN FUNCTION FAILURE ERROR CODE 21 - MAIN PROCESSOR UNABLE TO COMMUNICATE WITH
PTU BOARD.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A
Device Displays Incorrect Message|BREAS (B)(4) THAT A CUSTOMER HAS REPORTED THAT
THE DEVICE HAS SHOWED ERROR 39.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) FOR EVALUATION. THE EVALUATION
DETERMINED THAT THE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND WAS NOT
REPRODUCIBLE. FURTHER EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
BY RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST AND
HAD A TOTAL POWER FAILURE (TPF) EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
CENTER IN BREMEN, GERMANY AND AN EVALUATION WAS PERFORMED. THE EVALUATION
FAULTY EXPIRATORY FLOW SENSOR. THE EXPIRATORY FLOW SENSOR WAS REPLACED TO ADDRESS
THIS ISSUE. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE TOTAL POWER FAILURE
EVENT WAS A SINGLE OCCURRENCE AND WAS NOT REPRODUCIBLE DURING IN HOUSE TESTING.
ACCEPTABLE. (B)(4).
SYSTEM FAULT MESSAGES WERE OBSERVED ON AN ASTRAL DEVICE. THESE FAULTS RESULTED IN
AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGES. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED
TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION AND WAS RETURNED TO THE
Malfunction|Battery Problem;Device Stops Intermittently|IT WAS REPORTED TO RESMED
(B)(6) THAT AN ASTRAL DEVICE HAD A UNEXPECTED RESTART EVENT RESULTING IN A "BATTERY
INOPERABLE" ERROR MESSAGE. THIS ERROR MESSAGE RESULTED IN AN AUDIBLE ALARM WHICH
NOTIFIED THE REPORTER OF THE FAULT. THE DEVICE CONTINUED TO PROVIDE THERAPY AT THE
TIME THE ERROR MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN (B)(4) FOR EVALUATION AND WAS RETURNED TO THE INVESTIGATION FACILITY
Device Inoperable|(B)(4) DISTRIBUTOR REPORTED A DEVICE WITH PERMANENT ERROR #39 DUE
TO BLOWER MALFUNCTION. THE ERROR ALWAYS HAPPENS WHEN TREATMENT STARTS.|THIS
MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS
AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON
THE INFORMATION THAT BREAS PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE
Device Inoperable|DISTRIBUTOR IN (B)(4) REPORTED A DEVICE WHICH ALLEGEDLY DOESN'T
WORK, THE SCREEN IS BLACK AND THERE ONLY APPEARS A BATTERY SYMBOL WITH A "X".|THIS
5070154|20140101|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS|Malfunction|No
Flow;Device Inoperable|BREAS SERVICE CENTER IN (B)(4) ENCOUNTERED A DEVICE SHOWING
ERROR CODE #39.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL
AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A
Charging Problem|DISTRIBUTOR IN (B)(4) REPORTS A VIVO 50 DEVICE'S INTERNAL BATTERY
NOT BEING CHARGED.|DEVICE NOT RETURNED TO MANUFACTURER. THIS MEDWATCH REPORT IS A
RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED
Device Displays Incorrect Message|SERVICE TECHNICIAN FROM (B)(6) REPORTED THAT THE
DEVICE HAS SHOWN ERROR CODE 39.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A
Device Displays Incorrect Message|SERVICE CENTER IN (B)(4) REPORTS THAT THE DEVICE
HAS SHOWN ERROR CODE 4 DURING VENTILATION. ERROR CODE 4 INDICATES THAT THE SENSOR
FOR EXHALATION VALVE CONTROL PRESSURE FAILS.|UNDER (B)(4) LAW, PATIENT INFORMATION
Device Displays Incorrect Message|DISTRIBUTOR IN (B)(6) REPORTED THAT THE DEVICE
SHOWED ERROR 30 WHEN THEY TURNED THE UNIT ON.|THIS MEDWATCH REPORT IS A RESULT OF A
Failure to Power Up;Device Operational Issue|BREAS SERVICE CENTER IN (B)(4)
ENCOUNTERED A DEVICE WITH A BATTERY FAILURE. DEVICE WAS INOPERABLE AND DID NOT
RESPOND TO BUTTON PRESSES.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Device Displays Incorrect Message|(B)(4) DISTRIBUTOR REPORTED A VIVO 50 DEVICE
SHOWING AN INTERNAL FUNCTION FAILURE WITH ERROR CODE #39.|UNDER EUROPEAN LAW,
Device Displays Incorrect Message|DISTRIBUTOR IN (B)(4) REPORTS THAT THE DEVICE HAS
AN DEFECTIVE BLOWER, NOT GIVING ANY AIR AND THAT THE DEVICE SHOWED ERROR CODE 31.|
SHOWN ERROR CODE 19.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Device Displays Incorrect Message|DISTRIBUTOR IN (B)(4) REPORTS THAT A DEVICE HAS
SHOWN ERROR CODE 21.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF 189) WAS OBSERVED ON AN
ASTRAL DEVICE. THIS RESULTED IN AN AUDIBLE ALARM AND AN UNEXPECTED RESTART OF THE
DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN
EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
BY RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF 74 AND 223).
THE DEVICE ALSO FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED
TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION AND IS BEING RETURNED TO THE
DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
BY (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 218). THE DEVICE
ALSO FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST AND SYSTEM FAULT 218 WAS DUE
TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE
ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Device Displays Incorrect Message|(B)(6) HOSPITAL REPORTED A VIVO 50 DEVICE HAVING
STOPPED SEVERAL TIMES WHILE DISPLAYING ERROR CODES. INQUIRIES ABOUT PATIENT STATUS
HAVE NOT BEEN ANSWERED.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Device Displays Incorrect Message|AUTHORIZED DISTRIBUTOR IN (B)(6) REPORTED A VIVO
50 DEVICE WILL NOT START BUT DISPLAYING ERROR CODE #39.|THIS MEDWATCH REPORT IS A
5077025|20140101|NOU|Continuous, Ventilator, Home Use|VIVO 60|BREAS VIVO 60|
Malfunction|Device Displays Incorrect Message|BREAS (B)(4) REPORTED A VIVO 60
DEVICE WITH A BATTERY ISSUE. THE INTERNAL BATTERY ICON HAD A RED CROSS LIKE IF IT'S
OUT OF ORDER. WHEN WE HAVE RECONNECTED THE MAINS POWER, THE INTERNAL BATTERY ICON
CAME BACK IN GREEN AND THE CHARGE WAS RUNNING. THE VIVO 60 IS NOT MARKETED IN THE
USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A
SIMILAR MODEL.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL
AND WILL NOT BE RELEASED BY THE HOSPITAL. THE VIVO 60 IS NOT MARKETED IN THE USA,
BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A
SIMILAR MODEL. VIVO 60 DOES NOT HAVE A PRODUCT CODE LISTED SO THE VIVO 50 PRODUCT
CODE NOU IS USED. THE VIVO 50 510(K) NUMBER IS K123144. THIS MEDWATCH REPORT IS A
Failure To Run On AC/DC;Device Displays Incorrect Message|AUTHORIZED US DISTRIBUTOR
CLAIMS A VIVO 50 DEVICE REPORTEDLY STOPPED WORKING WHILE ON THE PATIENT AND GAVE
ERROR CODE #4 IN THE LOG.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
5077429|20140101|NOU|Continuous, Ventilator, Home Use|VIVO 60|BREAS|Malfunction|No
Display / Image|BREAS (B)(4) REPORTED THAT THE DEVICE HAD A DEFECTIVE SCREEN, THE
DEVICE WAS SENT TO BREAS (B)(4) FOR REPAIR.|THE VIVO 60 IS NOT MARKETED IN THE USA,
BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A
SIMILAR MODEL. VIVO 60 DOES NOT HAVE A PRODUCT CODE SO THE VIVO 50 PRODUCT CODE IS
USED. (B)(4). UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
Device Displays Incorrect Message;Battery Problem|BREAS (B)(4) REPORTS THAT THE
DEVICE HAS SHOWN ERROR CODE 39 AND THAT THE DEVICE NOT ALWAYS DETECT THE INTERNAL
BATTERY.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL
NOT BE RELEASED BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A
SHOWN ERROR CODE 39.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
TO RESMED (B)(4) THAT WHILE THE DEVICE WAS BEING SERVICED, IT DISPLAYED AN ERROR
MESSAGE (SF 74) INDICATING A SOFTWARE TASK ERROR. THE ASTRAL DEVICE FAILED TO PASS
ITS INTERNAL SELF-TEST AND WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE TRIGGERED A SERIES OF HIGH
OBSTRUCTION ALARMS CAUSING THE DEVICE TO RESTART UNEXPECTEDLY. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE ALARMS AND UNEXPECTED RESTART WAS DUE TO A DEFECTIVE
MAIN CIRCUIT BOARD (PCB). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
HAD A POWER FAILURE DURING TECHNICAL SERVICING. THE DEVICE WAS NOT IN USE WHEN THE
RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE
DEVICE SOFTWARE WAS RELOADED DURING SERVICING AND THE ASTRAL PERFORMED TO
SPECIFICATIONS. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
REPORTED TO RESMED THAT DURING PATIENT VENTILATION, A SYSTEM FAULT (SF 74) OCCURRED
ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK ERROR AND CAUSING THE DEVICE TO STOP
VENTILATION. THE PATIENT WAS PLACED ON A BACK-UP VENTILATOR AND WAS REPORTED TO BE
DOING FINE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE DEVICE SYSTEM FAULT 74 WAS DUE TO A DEFECTIVE
HEATING ELEMENT. THE DEVICE WAS SERVICED AND INSTALLED WITH A NEW HEATING ELEMENT
TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)
(4).
MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S
Malfunction|Device Displays Incorrect Message|AUTHORIZED DISTRIBUTOR IN (B)(4)
REPORTS A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #7.|UNDER (B)(4)
CLAIMS A VIVO 50 DEVICE DISPLAYED ERROR CODE #18. NO WARRANTY. NO REPLY FROM
CUSTOMER.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF
Malfunction|Failure To Run On AC/DC|AUTHORIZED DISTRIBUTOR IN (B)(4) REPORTS A VIVO
50 DEVICE SHOWING MULTIPLE PROBLEMS: CANNOT USE AC POWER TO RUN THE MACHINE. CANNOT
USE BUTTON AFTER TURN ON MACHINE IN A LONG PERIOD. NO REPLY FROM CUSTOMER.|THIS
Malfunction|Power Problem;Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE HAD A POWER FAULT WHILE USING THE EXTERNAL BATTERY. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO
THE RESMED TECHNICAL SERVICE CENTER IN PARIS, (B)(4) FOR EVALUATION. THE EVALUATION
Malfunction|Device Inoperable;Device Displays Incorrect Message;Battery Problem|IT
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE
ALARM FOLLOWED BY A SYSTEM FAULT (SF 74) ERROR MESSAGE. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION METHODS, RESULTS,
TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST AND
TRIGGERED AN AUDIBLE "HIGH PRESSURE OBSTRUCTION" ALARM. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST AND "HIGH
PRESSURE OBSTRUCTION" ALARM WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE
A SYSTEM FAULT (SF 74) ERROR MESSAGE WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING A
SOFTWARE TASK ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE SYSTEM
FAULT 74 WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED
HAD A DEFECTIVE POWER SUPPLY UNIT (PSU). THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE'S DEFECTIVE POWER SUPPLY UNIT (PSU) WAS DUE TO A DEFECTIVE POWER CORD.
(B)(4).
Malfunction|Battery Problem|BREAS (B)(4) REPORTS THAT THE DEVICE DOES NOT RECOGNIZE
THE INTERNAL BATTERY.|THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS REPORT IS
BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL. (B)(4).
Malfunction|Battery Problem|DISTRIBUTOR IN (B)(4) REPORTS THAT A VIVO 50 DOESN'T
RESPOND TO BUTTON PRESSES. WHEN TURNING THE DEVICE ON WITH AC OR DC TO STANDBY MODE
AND TRY TO START ON THE VENTILATION THERE IS NO RESPOND WHEN PRESSING THE PUSH
BUTTONS AND AFTER 11 SECONDS THE SCREEN BECOME COMPLETELY DARK. ALSO THE CUSTOMER
REPORTS THAT THE DEVICE DOES NOT RECOGNIZE THE INTERNAL BATTERY.|THIS MEDWATCH
Malfunction|Device Displays Incorrect Message|SERVICE DEPARTMENT IN A HOSPITAL IN
(B)(6) REPORTS THEY HAVE GOT THE FAULT DESCRIPTION "A PUFF OF SMOKE FROM REAR OF
THE MACHINE". THEY INVESTIGATED THE DEVICE AND FOUND ERROR CODE 34 AND 39 IN THE
LOG FILES.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
5084173|20150825|NOU|Continuous, Ventilator, Home Use|19620|ASTRAL BATTERY PACK|
INTERNAL BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE BATTERY
CHARGING FAILURE WAS DUE TO A MANUFACTURING DEFECT OF THE INTERNAL BATTERY. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
RESMED (B)(4) THAT A "BATTERY INOPERABLE" ERROR MESSAGE WAS DISPLAYED ON AN ASTRAL
DEVICE. THE RESULTED IN AN AUDIBLE ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4).
HAD A POWER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE POWER
FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU). THE PSU WAS REPLACED TO
ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THEIS FAILURE MODE CONCLUDES THAT
RESMED THAT A "BATTERY INOPERABLE" ERROR MESSAGE AND A SYSTEM FAULT (SF 180)
OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER FAULT. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS NOT
RETURNED FOR EVALUATION. A TECHNICAL EVALUATION WAS PERFORMED OVER THE PHONE BY A
RESMED PRODUCT SUPPORT SPECIALIST. THE EVALUATION DETERMINED THAT THE DEVICE
BATTERY INOPERABLE ERROR MESSAGE AND SYSTEM FAULT 180 WERE DUE TO AN ISOLATED
SOFTWARE TIMING ISSUE. THE DEVICE WAS REBOOTED TO ADDRESS THIS ISSUE. RESMED'S RISK
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED
REPORTS A VIVO 50 DEVICE NOT RECOGNIZING THE INTERNAL BATTERY.|THIS MEDWATCH REPORT
IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN
DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON THE
Malfunction|Device Displays Incorrect Message;Device Inoperable|BREAS SERVICE
CENTER IN (B)(6) REPORTS A VIVO 50 DEVICE DUE A POWER SUPPLY ISSUE.|UNDER (B)(4)
Malfunction|Device Displays Incorrect Message|BREAS SERVICE CENTER IN (B)(4)
REPORTS A VIVO 50 DEVICE DISPLAYING AN ERROR MESSAGE, CODE #39.|UNDER (B)(4) LAW,
Malfunction|Calibration Error;Battery Problem|BREAS (B)(4) REPORTS THAT THE DEVICE
DOES NOT RECOGNIZE THE INTERNAL BATTERY AND THAT THE DEVICE DOES NOT PASS THE FLOW
CALIBRATION. ALSO THE PSU-BOARD IS FAILING.|UNDER (B)(4) LAW, PATIENT INFORMATION
Malfunction|Battery Problem|DISTRIBUTOR IN (B)(4) REPORTS THAT THE DEVICE KEYBOARD
IS NOT FUNCTIONING AND THAT THE INTERNAL BATTERY DOES NOT STORE THE POWER.|THIS
Malfunction|Device Displays Incorrect Message;Noise, Audible|BREAS (B)(4) REPORTS
THAT THE DEVICE HAS AN DEFECTIVE BLOWER AND THAT THE DEVICE DOES NOT RECOGNIZE THE
INTERNAL BATTERY.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Malfunction|Device Displays Incorrect Message|BREAS (B)(4) REPORTS THAT THE DEVICE
HAS SHOWN ERROR CODE 18 AND 39.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
Malfunction|Failure To Run On AC/DC|DISTRIBUTOR IN (B)(4) REPORTS THAT THE DEVICE
CAN'T BE USED ON AC POWER. THE PSU-BOARD IS SUSPECTED TO BE FAULTY.|THIS MEDWATCH
Malfunction|Device Displays Incorrect Message|BREAS (B)(4) HAS REPORTED THAT THE
DEVICE HAS SHOWN ERROR CODE 30.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
AS A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO
THE INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON
THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). THE INVESTIGATION
Malfunction|Battery Problem|(B)(6) HOSPITAL REPORTS A VIVO 50 DEVICE DUE TO A
BATTERY ISSUE. THE INTERNAL BATTERY IS TEMPORARILY DISCONNECTED A WHILE AFTER AN
EXTERNAL BATTERY IS CONNECTED.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS
REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE LIFE
MALFUNCTION EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
ASSESSMENT TO REPORTABLE.
DEVICE HAD A POWER FAULT AND BECAME INOPERABLE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK
THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS
SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A
NON-REPORTABLE LIFE MALFUNCTION EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION
TO CHANGE THE ASSESSMENT TO REPORTABLE.
THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS
SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A
NON-REPORTABLE LIFE MALFUNCTION EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION
TO CHANGE THE ASSESSMENT TO REPORTABLE.
THE RETURNED ASTRAL DEVICE BY THE DESIGN HOUSE IN( B)(6). THE INVESTIGATION
Malfunction|Insufficient Cooling|BREAS SERVICE CENTER IN (B)(6) REPORTS A VIVO 50
DEVICE DUE TO A COOLING FAN FAILURE.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
REPORTS A VIVO 50 DEVICE SHOWING ERROR CODES #18 AND #39.|UNDER (B)(4) LAW, PATIENT
REPORTS A VIVO 50 DEVICE SHOWING ERROR CODES #18 AND #39.|THIS MEDWATCH REPORT IS A
REPORTS A VIVO 50 DEVICE SHOWING ERROR CODE #39 - DEVICE NOT STARTING.|UNDER (B)(4)
Malfunction|Device Displays Incorrect Message|BREAS (B)(4) REPORTED A VIVO 60
DEVICE SHOWING ERROR CODE #13. THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS
REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR
MODEL.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL
NOT BE RELEASED BY THE HOSPITAL. THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS
REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR
MODEL. (B)(4). THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF
REPORTS A VIVO 50 DEVICE SHOWING AN ERROR MESSAGE : "PRESSURE COMPENSATION LOST".|
Malfunction|Failure to Power Up;Device Displays Incorrect Message|AUTHORIZED
DISTRIBUTOR IN (B)(4) REPORTS A VIVO 50 DEVICE SHOWING AN ERROR MESSAGE, INTERNAL
FUNCTION FAILURE #39, DEVICE IS NOT STARTING.|THIS MEDWATCH REPORT IS A RESULT OF A
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|AN EXTENSIVE
ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE DESIGN
HOUSE IN (B)(4). THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE
ITS INTERNAL SELF-TEST WAS DUE TO THE INSPIRATORY FLOW SENSOR. RESMED'S RISK
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE:
AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS
ASSESSED AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. THE INVESTIGATION
IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
Malfunction|Fracture;Failure To Run On AC/DC|BREAS SERVICE CENTER IN (B)(6) REPORTS
A VIVO 50 DEVICE WITH A BROKEN CORNER AND NOT WORKING ON MAINS POWER.|UNDER
EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE
REPORTS A VIVO 50 DEVICE SHOWING ERROR CODES #3 AND #54 SEVERAL TIMES DURING
TREATMENT.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
REPORTS A VIVO 50 DEVICE NOT WORKING WITH BATTERY. THE BATTERY INDICATOR ON THE
SCREEN INDICATES THE BATTERY IS OUT OF ORDER.|THIS MEDWATCH REPORT IS A RESULT OF A
Malfunction|Device Displays Incorrect Message|HOSPITAL IN THE (B)(6) REPORTS A VIVO
50 DEVICE DISPLAYING ERROR MESSAGES: INTERNAL FUNCTION FAILURE CODES #9 AND #13.|
Malfunction|Device Displays Incorrect Message|DISTRIBUTOR IN (B)(4) REPORTS THAT
THE DEVICE STOPPED WITH ERROR CODE 54. THERE WAS NO HARM THE PATIENT AND THE DEVICE
COULD BE RESTARTED AND WORKED NORMALY.|THIS MEDWATCH REPORT IS A RESULT OF A
Malfunction|Device Displays Incorrect Message|BREAS (B)(4) REPORTS THAT DEVICE HAS
DISPLAYED ERROR CODE 30.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Malfunction|Device Inoperable;Device Displays Incorrect Message|BREAS SERVICE
CENTER IN (B)(4) REPORTS A VIVO 50 DEVICE DISPLAYING A RED FLASHING LED . DEVICE
INOPERABLE.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
Malfunction|Device Displays Incorrect Message|HOSPITAL IN (B)(6) REPORTED A VIVO 50
DEVICE AFTER SHOWING AN ERROR CODE, INTERNAL FUNCTION FAILURE #35.|UNDER (B)(4)
Malfunction|Failure To Run On AC/DC|BREAS SERVICE CENTER IN (B)(4) REPORTS A VIVO
50 DEVICE WITH DEFECTIVE INTERNAL BATTERY. THE FAILURE OCCURRED ONCE.|UNDER
Malfunction|Pumping Stopped;Failure to Deliver|AUTHORIZED DISTRIBUTOR IN (B)(4)
REPORTED A VIVO 60 DEVICE ALLEGEDLY STOPPED TREATMENT WHILE RUNNING, FOR NO
APPARENT REASON. IT WAS NOT ATTACHED TO THE PATIENT AT THE TIME. CORRECTIVE ACTION
WAS TAKEN AND THE VENTILATOR CHECKED AND DEEMED FIT FOR USE. THE VIVO 60 IS NOT
MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO
50 IN THE US IS A SIMILAR MODEL.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE VIVO 60 IS
NOT MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE
VIVO 50 IN THE US IS A SIMILAR MODEL. VIVO 60 DOES NOT HAVE A PRODUCT CODE LISTED
SO THE VIVO 50. THE VIVO 50 510(K) NUMBER IS (B)(4). THIS MEDWATCH REPORT IS A
REPORTED A VIVO 50 DEVICE DISPLAYING ERROR MESSAGES, INTERNAL FUNCTION FAILURE
CODES # 34 AND #39.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Malfunction|Increase in Pressure|CUSTOMER IN THE (B)(6) REPORTED A VIVO 50 DEVICE
DELIVERED INCORRECT PRESSURES, BEFORE AND AFTER PC BASED SERVICE, SET AT 22CM INSP
PRESSURE AND 6CM PEEP, PUTTING OUT 33CM AND 9,5CM.|UNDER (B)(4) LAW, PATIENT
Malfunction|Device Displays Incorrect Message|US CUSTOMER REPORTED A VIVO 50 DEVICE
DISPLAYING AN ERROR MESSAGE: ERROR CODE #21.|THIS MEDWATCH REPORT IS A RESULT OF A
REPORTED A VIVO 50 DEVICE DISPLAYING AN ERROR MESSAGE, INTERNAL FUNCTION FAILURE
CODE # 51.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
Malfunction|Device Displays Incorrect Message|DISTRIBUTOR IN (B)(4) REPORTED A VIVO
50 DEVICE DISPLAYING AN ERROR MESSAGE: ERROR CODE #39.|UNDER EUROPEAN LAW, PATIENT
Malfunction|Failure To Run On AC/DC|BREAS SERVICE CENTER IN (B)(4) REPORTED A VIVO
50 DEVICE WITH NO FUNCTION ON MAINS POWER, ONLY BATTERY OPERATION POSSIBLE.|UNDER
(B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED
BY THE HOSPITAL. THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION
OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT
Malfunction|Insufficient Cooling;Device Displays Incorrect Message|HOSPITAL IN THE
(B)(6) REPORTED A VIVO 50 DEVICE DISPLAYING SEVERAL "FUNCTION FAILURE 9" MESSAGES
AND GETTING HOT, THE SCREEN ALSO GREYS DURING OPERATION.|UNDER EUROPEAN LAW,
Malfunction|Device Displays Incorrect Message|BREAS MEDICAL (B)(6) REPORTS THAT THE
DEVICE HAS DISPLAYED ERROR CODE 30 AND THAT THE BUTTONS ARE DEFECTIVE.|UNDER
THE DEVICE HAS DISPLAYED ERROR CODE 21.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
Malfunction|Battery Problem|DISTRIBUTOR IN (B)(4) REPORTS THAT THE DEVICE DOES NOT
DETECT THE INTERNAL BATTERY.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE THE
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT WAS UNABLE TO POWER ON. THE
INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE DESIGN HOUSE LOCATED IN
(B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
THE DEVICE WAS FUNCTIONING TO SPECIFICATIONS. THERE WAS NO FAULT FOUND ON THE
RETURNED ASTRAL DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF 180) OCCURRED ON AN ASTRAL
DEVICE INDICATING A BATTERY CHARGER FAULT. THIS RESULTED IN AN UNEXPECTED RESTART
OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE USER ALLOWED THE
BATTERY TO DEPLETE CAUSING THE SYSTEM FAULT 180 AND UNEXPECTED RESTART. THE FAILURE
MODES WERE NOT REPRODUCIBLE DURING IN-HOUSE TESTING AFTER CHARGING THE BATTERY.
THERE WAS NO FAULT FOUND WITH THE RETURNED UNIT. THE DEVICE WAS SERVICED AND
RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO WATER
CONTAMINATION OF THE PRESSURE SENSOR. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
BY RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 74)
REPLACED TO ADDRESS THIS ISSUE. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE
DEVICE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND WAS NOT REPRODUCIBLE DURING IN-
HOUSE TESTING. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
Malfunction|Device Stops Intermittently;Power Problem|IT WAS REPORTED TO RESMED (B)
(4) THAT AN ASTRAL DEVICE HAD A POWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
TIME. RESMED REFERENCE #: (B)(4).
Malfunction|Device Displays Incorrect Message|DURING A ROUTINE SERVICE OF THE
ASTRAL DEVICE, IT WAS OBSERVED THAT A SYSTEM FAULT 74 HAD OCCURRED. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING
RETURNED TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
Malfunction|Device Displays Incorrect Message;No Flow|AUTHORIZED DISTRIBUTOR IN (B)
(6) REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #39.|THIS
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #39. DEVICE WAS
INOPERABLE SINCE BUTTONS WERE DEFECTIVE.|THIS MEDWATCH REPORT IS A RESULT OF A
Malfunction|Device Displays Incorrect Message;Failure to Deliver|AUTHORIZED
DISTRIBUTOR IN (B)(4) REPORTED A VIVO 50 DEVICE SINCE UNIT COULD BE TURNED ON BUT
COULD NOT VENTILATE. BURNT SMELL PRESENT.|THIS MEDWATCH REPORT IS A RESULT OF A
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODES #34 AND #39.|
AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT.
REPORTED A VIVO 50 DEVICE SHOWING ON THE SCREEN THAT THE INTERNAL BATTERY WAS NOT
RECOGNIZED.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #30. DEVICE WAS
INOPERABLE SINCE BUTTONS WERE DEFECTIVE.|THIS MEDWATCH REPORT IS A RESULT OF A
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #39.|UNDER (B)(4)
CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT.
Malfunction|Power Problem|BREAS (B)(4) REPORTS THAT THE DEVICE HAS A DEFECTIVE PSU-
BOARD, THE DEVICE DOES NOT RUN ON MAINS POWER.|UNDER EUROPEAN LAW, PATIENT
Malfunction|Device Displays Incorrect Message|BREAS (B)(6) REPORTS THAT THE DEVICE
HAS DISPLAYED ERROR MESSAGE PRESSURE COMPENSATION LOST.|UNDER EUROPEAN LAW, PATIENT
Malfunction|Device Issue|BREAS MEDICAL (B)(6) REPORTS THAT THE DEVICE IS WITHOUT
FUNCTION.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
THE DEVICE HAS DISPLAYED ERROR CODE 39.|THIS MEDWATCH REPORT IS A RESULT OF A
Malfunction|Device Operational Issue;Device Stops Intermittently|CUSTOMER IN USA
REPORTS THAT THE DEVICE WAS STACKING BREATHS WITH INCREASED TIDAL VOLUMES. VIVO
WOULD RANDOMLY STOP.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
Malfunction|Device Displays Incorrect Message|SERVICE TECHNICIAN AT A (B)(6)
HOSPITAL REPORTS THAT THE DEVICE HAS DISPLAYED ERROR CODE 33.|UNDER (B)(4) LAW,
Malfunction|Device Stops Intermittently|DISTRIBUTOR IN (B)(4) REPORTS THAT THE
DEVICE HAS SHUT DOWN A COUPLE OF TIMES AND THEN RESTARTED.|UNDER EUROPEAN LAW,
DEVICE HAS DISPLAYED ERROR CODE 51.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
DEVICE HAS DISPLAYED ERROR CODE 18.|UNDER (B)(4) LAW, PATIENT INFORMATION IS
REPORT FOR THIS EVENT.
Malfunction|Device Displays Incorrect Message|BREAS (B)(6) REPORTS THAT DEVICE
DISPLAYS ERROR 21.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED
DEVICE HAS DISPLAYED ERROR CODE 21.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
Malfunction|Volume Accuracy Problem|BREAS MEDICAL (B)(4) REPORTS THAT THE DEVICE
HAS A NOISY TURBINE AND THAT VOLUME LIMITS INTERMITTENTLY EXCEEDS.|UNDER EUROPEAN
Malfunction|Device Displays Incorrect Message|CUSTOMER IN (B)(6) REPORTS THAT THE
DEVICE HAS DISPLAYED ERROR CODE 9 AND 13.|UNDER EUROPEAN LAW, PATIENT INFORMATION
Malfunction|Battery Problem|CUSTOMER REPORTS THAT THE DEVICE HAS AN INTERNAL
BATTERY FAILURE.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION
OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODE #39.|UNDER
REPORTED A VIVO 50 DEVICE SHOWING INTERNAL FUNCTION FAILURE CODES #12 AND #39.|
UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE
Malfunction|Device Displays Incorrect Message|CUSTOMER SERVICE CENTER IN THE US
REPORTED A VIVO 50 DEVICE DISPLAYING ERROR CODES #33 AND #39 WITH LOW MV ALARMS.|
Malfunction|Device Displays Incorrect Message|CUSTOMER SERVICE CENTER IN THE US
REPORTED A VIVO 50 WITH INTERNAL FUNCTION FAILURE #39 FOUND DURING INITIAL SET UP
BEFORE SENDING TO CUSTOMER.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE
Malfunction|Device Sensing Problem|BREAS SERVICE CENTER IN (B)(6) REPORTED A VIVO
50 DEVICE FOUND TRIGGERING BY ITSELF.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
REPORTED A VIVO 50 DEVICE DISPLAYING ERROR CODE #13 WHEN AC CORD WAS INSERTED IN
THE DEVICE AND THE POWER ON/OFF SWITCH WAS TURNED ON.|THIS MEDWATCH REPORT IS A
DEVICE INDICATING A BATTERY CHARGER FAULT. THIS RESULTED IN THE UNEXPECTED RESTART
UNEXPECTED RESTART WERE DUE TO A SOFTWARE PROBLEM. THE DEVICE WAS SERVICED TO
DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4). NOTE: AT THE TIME THIS SELF-TEST, COMPLAINT WAS REPORTED TO THE
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE LIFE MALFUNCTION EVENT. THE
INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
Malfunction|Battery Problem;Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT
AN ASTRAL DEVICE'S INTERNAL BATTERY BECAME INOPERABLE. THIS RESULTED IN THE DEVICE
PERFORMING AN UNEXPECTED RESTART. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR
Malfunction|Device Inoperable;Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT
AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM THAT RESULTED IN A POWER
FAILURE FOLLOWED BY AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN
HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
RESMED REFERENCE #: (B)(4).
TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS
REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD
BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO
CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE
UNEXPECTED RESTART OCCURRED HOWEVER IN-HOUSE TESTING WAS UNABLE TO REPRODUCE THE
FAILURE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED
DISPLAYED A BATTERY INOPERABLE ALARM FOLLOWED BY A SYSTEM FAULT 74 ERROR MESSAGE.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS
AT THIS STAGE. RESMED REFERENCE #: (B)(4).
Malfunction|Power Problem;Failure to Power Up|IT WAS REPORTED TO RESMED (B)(4) THAT
WHILE AN ASTRAL DEVICE WAS IN STANDBY MODE AND NOT IN USE, IT POWERED DOWN AND WAS
UNABLE TO TURN BACK ON. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE USER ALLOWED THE DEVICE TO ENTER STAND BY MODE CAUSING THE
DEVICE TO BE POWERED DOWN BY A TIMER. THE FAILURE MODE WAS NOT REPRODUCIBLE DURING
IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED UNIT. RESMED'S RISK
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, THE BATTERY WOULD NOT CHARGE. THE
INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT FAILED TO PASS ITS INTERNAL
NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
CENTER IN PARIS, (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
Malfunction|Failure To Run On AC/DC;Power Problem;Crack;Material Integrity Problem|
HOSPITAL TECHNICIAN IN (B)(6) REPORTS A PROBLEM WITH A VIVO 50 VENTILATOR, STATING:
"THE DEVICE DOES NOT RUN ON MAINS POWER. IT HAS PROBABLY BEEN DROPPED ON THE FLOOR
SINCE THE CASING IS DAMAGED AT ONE CORNER." NO PATIENT INFORMATION HAS BEEN
PROVIDED DESPITE MULTIPLE ATTEMPTS AND REMINDERS.|UNDER EUROPEAN LAW, PATIENT
BASED UPON THE INFORMATION THAT BREAS MEDICAL PRESENTLY POSSESSES, WITH LIMITED
PATIENT INFORMATION, IT IS UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE UNDER
IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT.
A SYSTEM FAULT (SF 197) WAS DISPLAYED ON AN ASTRAL DEVICE INDICATING AN OUTLET FLOW
SENSOR ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 197 WAS
DUE TO WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR
Malfunction|Alarm Not Visible;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED (B)(4) THAT WHILE AN ASTRAL WAS BEING SERVICED, IT RESTARTED UNEXPECTEDLY.
DURING THE SERVICE EVENT IT WAS ALSO OBSERVED THAT THE DEVICE'S ALARM MUTE / RESET
BUTTON WAS NOT ILLUMINATING. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE UNEXPECTED RESTART WAS A SINGLE OCCURRENCE AT THE DISTRIBUTOR
LEVEL AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. FURTHER TECHNICAL
EVALUATION DETERMINED THAT THE FAULTY ALARM / MUTE BUTTON WAS DUE TO A DEFECTIVE
TOP CASE ASSEMBLY. THE TOP CASE ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE.
ACCEPTABLE. (B)(4).
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, THE INTERNAL BATTERY WOULD NOT CHARGE.
INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN
BREMEN, GERMANY AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
DEVICE FAILURE TO CHARGE ITS BATTERY WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS A
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO
FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE
ACCEPTABLE. (B)(4).
REPORTED TO RESMED (B)(4) THAT SYSTEM FAULT MESSAGES (SF 75 AND 218) WERE OBSERVED
ON AN ASTRAL DEVICE. THIS RESULTED IN A DEVICE POWER FAILURE. THERE WAS NO PATIENT
DETERMINED THAT THE SYSTEM FAULT 75 AND POWER FAILURE WERE BOTH SINGLE OCCURRENCES
AND WERE NOT REPRODUCIBLE DURING IN-HOUSE TESTING. FURTHER TECHNICAL EVALUATION
DETERMINED THAT THE SYSTEM FAULT 218 WAS DUE TO A CALIBRATION ISSUE. THE DEVICE WAS
RECALIBRATED AND SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
FAILURE TO CHARGE ITS BATTERY WAS DUE TO A DEFECTIVE INTERNAL BATTERY. RESMED'S
A SYSTEM FAULT (SF 147) MESSAGE WAS OBSERVED ON AN ASTRAL DEVICE. THIS RESULTED IN
AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, ITS DISPLAY SCREEN WAS INOPERABLE. THE
INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE DESIGN HOUSE LOCATED IN
RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT
DISPLAYED A BATTERY INOPERABLE ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF
74) INDICATING A SOFTWARE TASK ERROR. THIS RESULTED IN AN UNEXPECTED RESTART OF THE
UNEXPECTED RESTART WERE SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE ASTRAL WAS
SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
5134323|20150731|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50|Injury|
Infusion or Flow Problem|HOME CARE PROVIDER IN (B)(6) REPORTS AND INCIDENT WITH A
VIVO 50 VENTILATOR, STATING: "THE PATIENT'S PARENTS WERE WOKEN BY THE ALARM OF THE
VIVO 50 AT 7:00 AM ON (B)(6). THE PATIENT WAS IN RESPIRATORY CARDIAC ARREST. THE
EMERGENCY MEDICAL SERVICE WAS IMMEDIATELY CONTACTED TO TAKE CARE OF THE PATIENT.
SINCE THE INCIDENT, THE PATIENT IS IN A COMA WITH SEVERE NEUROLOGICAL DAMAGE.|UNDER
RELEASED BY THE HOSPITAL. THE DEVICE VIVO 50 (B)(4) HAS NOT BEEN FOUND DEFECTIVE OR
OUTSIDE OF ITS SPECIFICATIONS OR TOLERANCES. THE USED PRESSURE CONTROLLED OPERATING
MODE IMPLIES THAT THE VOLUMES DELIVERED CAN BE VARYING, AND SAFE ALARM LIMITS MUST
BE SET ACCORDINGLY AND TREATMENT MUST BE ADEQUATELY SUPERVISED. THE LOG FILES
CONFIRM THAT NO ONE RESPONDED TO THE ALARMS GIVEN BY THE DEVICE FOR MORE THAN 20
MINUTES. THE REPORTED INCIDENT IS CONSIDERED A RESULT OF A USE ERROR AND IS
REPORTABLE IN THE USA UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA
REGULATIONS AND GUIDANCE. THIS INCIDENT HAS ADDITIONALLY BEEN REPORTED TO THE (B)
(4).
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A CONTAMINATED
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DISCONNECTED
PEEP CONTROL TUBE WITHIN THE PNEUMATIC BLOCK. THE CONTROL TUBE WAS RECONNECTED AND
THE DEVICE WAS SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO THE SENSOR PCB
WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE STOPPED VENTILATION AND DISPLAYED
THE ERROR MESSAGE "INADEQUATE ADAPTER". THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION WAS UNABLE TO
CONFIRM THE REPORTED ISSUE. HOWEVER, DURING THE TECHNICAL EVALUATION A SELF-TEST
ISSUE WAS OBSERVED. THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE THE PNEUMATIC
BLOCK. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT'S SCREEN BECAME INOPERABLE
AND TURNED BLACK. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL
THAT THE DISPLAY FAILURE WAS DUE TO A DEFECTIVE LCD MODULE. RESMED'S RISK ANAYLSIS
FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
Malfunction|Battery Problem;Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE WOULD NOT RECOGNIZE WHEN THE AC MAIN POWER WAS CONNECTED. THERE WAS NO
EVALUATION DETERMINED THAT THE DEVICE NOT RECOGNIZING THE AC MAINS POWER ISSUE WAS
DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN CIRCUIT BOARD (PCB) WAS
RESMED THAT AN ASTRAL DEVICE WAS UNABLE TO RECOGNIZE THE AC MAINS POWER SOURCE.
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN SAN DIEGO, CALIFORNIA AND AN
EVALUATION WAS PERFORMED. THE EVALUATION FOUND A SYSTEM FAULT 74 AND THE AC MAINS
POWER SOURCE FAULT WERE DUE TO A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN CIRCUIT
BOARD (PCB) WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ERROR MESSAGE. THIS
RESULTED IN AN AUDIBLE ALARM WHICH NOTIFIED THE CAREGIVER OF THE MESSAGE. THERE WAS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY
EVALUATION DETERMINED THAT THE BATTERY INOPERABLE ERROR MESSAGE WAS DUE TO A
DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
WHILE AN ASTRAL DEVICE WAS BEING SERVICED AT THE DISTRIBUTOR SITE, IT DISPLAYED AND
ERROR MESSAGE (SF 65). THIS RESULTED IN AN AUDIBLE ALARM WHICH NOTIFIED THE
REPORTER OF THE FAULT. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE SYSTEM FAULT 65 WAS A SINGLE OCCURRENCE AND FUNCTIONED AS
DESIGNED UNDER NORMAL ALARM CONDITIONS. THE FAULT WAS NOT REPRODUCIBLE DURING IN-
HOUSE TESTING AND THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 218) INDICATING THAT THE OUTLET
PRESSURE MEASUREMENT MAY BE INCCORECT. THERE WAS NO PATIENT INJURY REPORTED AS A
THE SYSTEM FAULT 218 WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB
WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE
5147027|20150904|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50|Injury|
Insufficient Information|HOME CARE PROVIDER IN (B)(6) REPORTS AN INCIDENT WITH A
VIVO 50 VENTILATOR. THE PATIENT (VENTILATED WITH A TRACHEOSTOMY) WAS FOUND
STRETCHED OUT AT THE FOOT OF HER BED IN A STATE OF HYPERTHERMIA AND IN A COMA, AT
6:00 AM ON (B)(6). IT SEEMS SHE WAS NOT VENTILATED AT THE TIME. HOWEVER, THE DEVICE
HAS NOT YET BEEN MADE AVAILABLE FOR INVESTIGATION, AND THE LOG FILES INITIALLY
PROVIDED BY THE HOME CARE PROVIDER TURNED OUT TO BE PARTLY CORRUPTED. CURRENTLY IT
IS THEREFORE UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO
THE INCIDENT. NO CONCLUSIONS CAN BE DRAWN AT THIS POINT IN TIME TO WHAT CAUSED THE
EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, AS E.G. AFTER
RETURN OF THE DEVICE TO BREAS MEDICAL, A FOLLOW-UP REPORT WILL BE SUBMITTED.|UNDER
RELEASED BY THE HOSPITAL. IT IS CURRENTLY UNKNOWN WHETHER OR NOT THE DEVICE MAY
HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. NO CONCLUSIONS CAN BE DRAWN AT THIS
POINT IN TIME AS TO WHAT CAUSED THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION
BECOME AVAILABLE, AS E.G. AFTER RETURN OF THE DEVICE TO BREAS MEDICAL, A FOLLOW-UP
REPORT WILL BE SUBMITTED. THIS INCIDENT HAS ADDITIONALLY BEEN REPORTED TO THE (B)
(4), IN MANUFACTURER'S VIGILANCE REPORT NO. (B)(4).
RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR USE, IT HAD A
BATTERY FAULT AND DISPLAYED ERROR MESSAGES "UNEXPECTED RESTART", AND "BATTERY
INOPERABLE". THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
WAS NO PATIENT INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE DESIGN
(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE STOPPED VENTILATION AND DISPLAYED AN ERROR
MESSAGE (SF 75) INDICATING THE PNEUMATIC BLOCK SOFTWARE WAS NOT CALIBRATING. THE
PATIENT WAS MANUALLY VENTILATED AND TAKEN TO THE HOSPITAL BY CAREGIVERS. THERE WAS
THE RESMED TECHNICAL SERVICE CENTER LOCATED IN (B)(6) FOR AN EVALUATION. THE
EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)
(4).
DEVICE FAILED TO PASS ITS LED LIGHT TEST. THERE WAS NO PATIENT INJURY REPORTED AS A
THE LED TEST FAILURE WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB) AND TOP CASE
ASSEMBLY. THE MAIN PCB AND TOP CASE ASSEMBLY WERE REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN PARIS, FRANCE AND AN
SINGLE OCCURRENCE AND WAS NOT REPRODUCIBLE DURING IN-HOUSE TESTING. THERE WAS NO
CUSTOMER. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 197) INDICATING AN OUTLET FLOW
SENSOR ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
LOCATED IN (B)(6) FOR EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. (B)(4).
BY RESMED (B)(4) THAT A SYSTEM FAULT (SF 223) WAS OBSERVED IN THE DEVICE LOG OF AN
ASTRAL DEVICE INDICATING A POSITIVE END EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE.
THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE FAILED TO PASS ITS INTERNAL SELF-
WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6)AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE SYSTEM FAULT 223 AND DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS
(B)(4).
RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
DEVICE HAD A DELAYED POWER-UP AFTER AN AUTO POWER-OFF EVENT WHILE USING AN EXTERNAL
BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN SYDNEY,
AUSTRALIA FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
DURING SERVICING OF THE ASTRAL DEVICE, SYSTEM FAULTS 74 AND 218 WERE OBSERVED IN
THE DEVICE LOG. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE
WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
CENTER IN (B)(6)AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
SYSTEM FAULTS 74 AND 218 WERE BOTH NOT REPRODUCIBLE DURING IN-HOUSE TESTING AND THE
DEVICE FUNCTIONED WITHIN SPECIFICATIONS. THERE WAS NO FAULT FOUND WITH THE RETURNED
DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
Malfunction|No Flow;Fail-Safe Design Failure|DUSTRIBUTOR IN (B)(6) REPORTED A VIVO
60 VENTILATOR STOPPED TREATMENT WITHOUT GIVING ALARM. THERE WAS NO HARM TO THE
PATIENT AS A RESULT OF THE EVENT, AS CARE GIVER WAS PRESENT NEXT TO THE PATIENT.
THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE
FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL.|UNDER EUROPEAN LAW, PATIENT
FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL. THEREFORE, THE VIVO 50 PRODUCT
CODE NOU, THE VIVO 50 510(K) # (B)(4), AND THE VIVO 50 UDI # (B)(4) HAVE BEEN USED
IN THIS REPORT.
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM
RESULTING IN THE UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE BATTERY INOPERABLE ALARM AND UNEXPECTED RESTART WERE BOTH
SINGLE OCCURRENCES AND COULD NOT BE REPRODUCIBLE DURING IN-HOUSE TESTING. THE
DEVICE FUNCTIONED WITHIN SPECIFICATIONS AND THERE WAS NO FAULT FOUND WITH THE
RETURNED UNIT. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
Malfunction|Inappropriate or Unexpected Reset;Charging Problem|IT WAS REPORTED TO
RESMED (B)(4)THAT AN ASTRAL DEVICE'S BATTERY WOULD NOT CHARGE. THIS RESULTED IN A
CRITICALLY LOW BATTERY ALARM, THEN A TOTAL POWER FAILURE, AND UNEXPECTED RESTART OF
THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE DEVICE CHARGING FAULT, POWER FAILURE, AND
UNEXPECTED RESTART WERE ALL DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL
BATTERY AND POWER SUPPLY UNIT (PSU) WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S
REPORTED TO RESMED THAT AN ERROR MESSAGE (SF 74) WAS OBSERVED ON AN ASTRAL DEVICE
INDICATING A SOFTWARE TASK ERROR. THIS RESULTED IN THE VENTILATION STOPPING. THE
PATIENT WAS BAGGED AND PLACED ON A BACK-UP VENTILATOR. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR
INVESTIGATION. A RESMED CLINICAL PRODUCT SPECIALIST PERFORMED AN EVALUATION BY
PHONE WITH THE RESPIRATORY CARE SPECIALIST THAT REPORTED THE DEVICE MALFUNCTION.
THE EVALUATION DETERMINED THAT THE SINGLE OCCURRENCE OF SYSTEM FAULT 74 AND
VENTILATION STOP WAS MOST LIKELY DUE TO AN ISOLATED SOFTWARE FAULT. THE RESPIRATORY
CARE SPECIALIST PERFORMED A SYSTEM LEARN CIRCUIT TO ADDRESS THIS ISSUE. RESMED'S
DEVICE INDICATING A BATTERY CHARGER FAULT. THIS RESULTED IN A POWER FAILURE AND
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) FOR
EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT YET FINALIZED
Malfunction|Device Displays Incorrect Message;Charging Problem|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM AND THE
BATTERY WOULD NOT CHARGE. THIS RESULTED IN AN UNEXPECTED RESTART AND POWER FAILURE
THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4)
FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
Malfunction|Inappropriate or Unexpected Reset;No Display / Image|IT WAS REPORTED TO
RESMED (B)(4) THAT WHILE THE ASTRAL DEVICE WAS IN STANDBY MODE AND NOT DELIVERING
THERAPY, IT DISPLAYED A RED SCREEN AND STOPPED VENTILATION. THIS RESULTED IN AN
UNEXPECTED RESTART AND POWER FAILURE ALARM. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE IS
CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN
WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS NOT DELIVERING
THERAPY, IT DISPLAYED AN ERROR MESSAGE (SF 219). THIS RESULTED IN AN UNEXPECTED
RESTART OF THE DEVICE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
TECHNICAL SERVICE CENTER IN BREMEN, GERMANY FOR EVALUATION. THE EVALUATION METHODS,
RESULTS, AND CONCLUSION ARE NOT YET FINALIZED AT THIS STAGE. (B)(4).
A SERIES OF SYSTEM FAULT ERROR MESSAGES WERE OBSERVED IN THE DEVICE LOG. THERE WAS
EVALUATION DETERMINED THAT THE SINGLE OCCURRENCES OF SYSTEM FAULTS 74, 195, 196,
AND 218 WERE DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED
TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
ASTRAL DEVICE DISPLAYED A HIGH PRESSURE ERROR MESSAGE WITH NO REPORTED AIR FLOW.
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE
EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT YET FINALIZED AT THIS STAGE.
(B)(4).
(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(4) THAT WHILE AN
ASTRAL DEVICE WAS BEING TESTED BY THEIR FACILITY, IT FAILED TO PASS ITS INTERNAL
NO PATIENT INVOLVEMENT.|RESMED TECHNICAL SERVICE CENTER IN (B)(4) PERFORMED AN
EVALUATION. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
(4).
FAULTY NON-RETURN VALVE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE
TO RESMED (B)(6) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST.
DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A SYSTEM FAULT 74 WAS ALSO
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PRESSURE SENSOR. FURTHER
EVALUATION DETERMINED THAT THE SINGLE OCCURRENCE OF SYSTEM FAULT 74 WAS DUE TO A
DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE PRESSURE SENSOR AND MAIN PCB WERE REPLACED
THAT THE RISK IS ACCEPTABLE.
Malfunction|Failure to Calibrate;No Display / Image|IT WAS REPORTED BY RESMED (B)
(4)THAT AN ASTRAL DEVICE HAD AN INOPERABLE DISPLAY SCREEN AND FAILED TO PASS ITS
INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAILURE
WAS DUE TO PHYSICAL DAMAGE TO THE TOP CASE COMPONENT. FURTHER INVESTIGATION
DEFECTIVE PNEUMATIC BLOCK. THE TOP CASE COMPONENT AND PNEUMATIC BLOCK WERE REPLACED
TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS
ASSESSED AS BEING A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW
INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY NON-
RETURN VALVE. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
HAD A DEFECTIVE BATTERY. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|RESMED HAS REQUESTED FOR THE DEVICE TO
NO PATIENT INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE
RETURN VALVE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE WITH A RED DISPLAY SCREEN. THIS
RESULTED IN AN AUDIBLE ALARM TO ALERT THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR
SYSTEM FAULT MESSAGES (SF 74 AND 223) WERE OBSERVED ON AN ASTRAL DEVICE. THESE
MESSAGES RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE FAULTS. THERE WAS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR
CENTER IN PARIS, FRANCE AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT WHILE
AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED ERROR MESSAGES
INDICATING THAT THE SELF-TEST FAILED. THIS MESSAGE RESULTED IN AN ALARM WHICH
NOTIFIED THE CAREGIVER OF THE FAULT. DURING THE SERVICE CENTER EVALUATION OF THE
DEVICE LOGS, A SYSTEM FAULT 74, AND 218 WERE ALSO OBSERVED. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE ERROR MESSAGES
WERE DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO
ADDRESS THESE ISSUES. (B)(4).
FAULTY INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST
REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE STOPPED VENTILATING DURING THERAPY. THE PATIENT WAS MANUALLY VENTILATED AND
PLACED ON A BACK-UP DEVICE BY A RESPIRATORY THERAPIST. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO THE
MANUFACTURER FOR EVALUATION. THE DEVICE WAS EVALUATED BY A RESMED DISTRIBUTOR IN
THE UNITED STATES. THE QUALITY MEDICAL BIOMED EVALUATION DETERMINED THAT THE DEVICE
STOPPING VENTILATION WAS DUE TO A CALIBRATION FAULT. THE DEVICE WAS RECALIBRATED,
SERVICED, AND RETURNED TO THE CUSTOMER. (B)(4).
EUR4|Malfunction|Device Displays Incorrect Message;No Display / Image|IT WAS
REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A DISPLAY FAILURE. DURING THE
SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A SYSTEM FAULT 218 WAS ALSO OBSERVED.
PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAILURE WAS DUE TO PHYSICAL
DAMAGE TO THE TOP CASE COMPONENT. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE
SYSTEM FAULT 218 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS
REPLACED TO ADDRESS THE DISPLAY FAILURE ISSUE. RESMED'S RISK ANALYSIS FOR THESE
FAULTY INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 180) INDICATING A BATTERY
CHARGER FAULT. IT WAS ALSO REPORTED THAT THE DEVICE HAD A POWER FAILURE AND
UNEXPECTED RESTART. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED ISSUE
WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO
DEVICE WAS RETURNED TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE DEVICE HAD A
DEFECTIVE INSPIRATORY FLOW SENSOR. (B)(4).
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED AN ERROR MESSAGE "CRITICAL BATTERY FAULT, SWITCH TO BACKUP VENTILATOR."
THE PATIENT THERAPY WAS NOT AFFECTED BY THIS MESSAGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO THE
MANUFACTURER FOR EVALUATION. THE DEVICE WAS EVALUATED BY A RESMED DISTRIBUTOR IN
THE UNITED STATES. A RESMED CLINICAL PRODUCT SUPPORT SPECIALIST FOLLOWED-UP WITH
THE BIO-ONE EMPLOYEE WHO MANAGES THE EVALUATION REPORTS. BASED ON ALL AVAILABLE
INFORMATION, THE ROOT CAUSE OF THIS CRITICAL BATTERY FAULT WAS MOST LIKELY A USER
ERROR BY ALLOWING THE DEVICE BATTERY TO DEPLETE. (B)(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 101)
INDICATING AN OUTLET PRESSURE ISSUE. THE VENTILATION STOPPED AS A RESULT OF THIS
ERROR MESSAGE. THE PATIENT WAS MANUALLY VENTILATED AND TAKEN TO THE EMERGENCY ROOM
WHERE THEY WERE PLACED ON A BACK-UP VENTILATOR. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE PRELIMINARY
EVALUATION DETERMINED THAT THE DEVICE FAULT WAS MOST LIKELY CAUSED BY PHYSICAL
DAMAGE TO THE AIR INLET FILTER COVER AND ALARM MUTE BUTTON. THE DEVICE IS CURRENTLY
BEING RETURNED TO THE DESIGN HOUSE LOCATED IN SYDNEY, AUSTRALIA FOR AN EXTENSIVE
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(4) THAT DURING
INCOMING INSPECTION, AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
ASTRAL DEVICE BY THE DESIGN HOUSE IN (B)(4). THE INVESTIGATION DETERMINED THAT THE
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY INSPIRATORY
FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO
THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE INVESTIGATION
WAS UNABLE TO CHARGE ITS INTERNAL BATTERY. THIS RESULTED IN AN AUDIBLE ALARM TO
NOTIFY THE CAREGIVER OF THE FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING FAULT WAS DUE
TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. RESMED REFERENCE #: (B)(4).
OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY
THE DESIGN HOUSE IN (B)(4). THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST, AND SYSTEM FAULT 74 WERE DUE TO A FAULTY
INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
Malfunction|No Display / Image|IT WAS REPORTED BY RESMED THAT AN ASTRAL DEVICE HAD
AN INOPERABLE TOUCH PANEL. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE TOUCH SCREEN
FAULT WAS DUE TO A DEFECTIVE TOP CASE COMPONENT. THE TOP CASE COMPONENT WAS
Malfunction|Charging Problem|IT WAS REPORTED BY RESMED THAT AN ASTRAL DEVICE WAS
UNABLE TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
THE CHARGING FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY
WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
BATTERY, AMERICAS|Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE HAD A DEFECTIVE EXTERNAL BATTERY. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL EXTERNAL BATTERY WAS NOT RETURNED
TO THE MANUFACTURER FOR EVALUATION. A RESMED CLINICAL PRODUCT SUPPORT SPECIALIST
DETERMINED THAT EXTERNAL BATTERY NEEDED TO BE REPLACED THROUGH OVER THE PHONE
TROUBLESHOOTING. RESMED PROVIDED THE CUSTOMER WITH A REPLACEMENT EXTERNAL BATTERY
TO ADDRESS THIS ISSUE. (B)(4).
THAT WHILE AN ASTRAL DEVICE WAS IN STANDBY MODE AND NOT IN USE, THE AUTO-POWER OFF
FUNCTION WAS ENABLED AND THE DISPLAY SCREEN WAS INOPERABLE. THERE WAS NO PATIENT
DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE AUTO-POWER
OFF FEATURE WAS TRIGGERED CORRECTLY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
RESMED (B)(4) THAT AN ASTRAL DEVICE'S BATTERY WOULD NOT FULLY CHARGE. IT WAS ALSO
REPORTED THAT THE UNIT DISPLAYED A SYSTEM FAULT 74 INDICATING A SOFTWARE TASK
DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE
DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A SINGLE OCCURRENCE OF
SYSTEM FAULT 74 WAS ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR
AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE
SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE
TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS
DISPLAYED A "BATTERY INOPERABLE" ERROR MESSAGE. THIS RESULTED IN AN ALARM WHICH
NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE FOR
Malfunction|Inappropriate or Unexpected Reset;Failure to Calibrate;Device Displays
Incorrect Message|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO
COMPLETE ITS INTERNAL SELF-TEST. IT WAS ALSO REPORTED THAT THE UNIT DISPLAYED
SYSTEM FAULT ERROR MESSAGES AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO WATER CONTAMINATION WITHIN THE
PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 180) INDICATING A BATTERY
CHARGER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A RED SCREEN WITH AN
ERROR MESSAGE AND BECAME INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
REPORTED BY A RESMED ACCOUNT MANAGER THAT WHILE AN ASTRAL DEVICE WAS BEING
DEMONSTRATED, IT DISPLAYED A SYSTEM FAULT ERROR MESSAGE (SF 101) INDICATING THAT
THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THIS FAULT CAUSED THE DEVICE TO
STOP VENTILATION. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN
HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 180) INDICATING A
BATTERY CHARGER FAULT. DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A
BATTERY INOPERABLE ERROR MESSAGE WAS ALSO OBSERVED. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(4). AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE
REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED
DEVICE. (B)(4).
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE FOR AN
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, ITS DISPLAY BUTTONS WERE
INTERMITTENTLY UNRESPONSIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
COULD NOT RECOGNIZE ITS POWER SUPPLY UNIT (PSU). THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAILURE TO RECOGNIZE ITS POWER SUPPLY UNIT WAS DUE TO A
DEFECTIVE PSU. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
(B)(4).
POWER SUPPLY UNIT (PSU) HAD NO FUNCTION. THERE WAS NO PATIENT INJURY REPORTED AS A
THE POWER FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT. THE PSU WAS REPLACED TO
Malfunction|Premature Discharge of Battery|DISTRIBUTOR IN THE USA REPORTS A PROBLEM
WITH A VIVO 50 HOME CARE VENTILATOR, STATING: "INTERNAL BATTERY DOES NOT SEEM TO
HOLD A CHARGE, FRONT SCREEN BROKE WITH A VERY SMALL IMPACT." THEIR CLIENT WAS TOLD
BOTH ISSUES WOULD BE REPAIRED UNDER WARRANTY. THE REPORTER CLAIMS THERE WAS NO
PATIENT INJURY AS A RESULT OF THE REPORTED FAILURE, BUT NO INFORMATION IS GIVEN AS
TO WHETHER THE DEVICE HAS ACTUALLY SIGNALED OR WARNED THE USER OF A PENDING BATTERY
ISSUE.|BASED UPON THE INFORMATION THAT BREAS MEDICAL PRESENTLY POSSESSES, IT IS
Malfunction|Decrease in Pressure|AUTHORIZED DISTRIBUTOR IN THE (B)(6) REPORTS A
PROBLEM WITH A VIVO 50 HOME CARE VENTILATOR, STATING: "IN THE BEGINNING OF (B)(6)
2015 THE PATIENT STARTS TO FEEL SHORTNESS OF BREATH WHEN HE USES THIS MACHINE."
ALLEGEDLY, THE DELIVERED PRESSURE WAS NOT CORRECT. THE REPORTER CLAIMS THERE WAS NO
PATIENT INJURY AS A RESULT OF THE REPORTED FAILURE, BUT NO INFORMATION IS GIVEN AS
TO WHETHER THE DEVICE ACTUALLY GAVE ANY ALARM FOR INCORRECT PRESSURE.|UNDER (B)(4)
HOSPITAL. BASED UPON THE INFORMATION THAT BREAS MEDICAL PRESENTLY POSSESSES, IT IS
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY
(B)(4).
ASTRAL|Malfunction|Temperature Problem|IT WAS REPORTED BY RESMED (B)(4) THAT DURING
THE SERVICE EVALUATION, AN ASTRAL DEVICE FAILED TO COMPLETE ITS TEMPERATURE MOTOR
TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER
DEVICE TEMPERATURE MOTOR TEST FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ERROR MESSAGE
FOLLOWED BY A NOTICE TO REPLACE THE VENTILATOR. THE DEVICE CONTINUED VENTILATION
DURING THE BATTERY INOPERABLE ALARM. THE PATIENT WAS PLACED ON A BACKUP VENTILATOR
WITH NO COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE
NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, SYSTEM FAULTS 74 AND 218
WERE ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE
TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. FURTHER
EVALUATION DETERMINED THAT THE SYSTEM FAULTS 74 AND 218 WERE SINGLE OCCURRENCES AND
COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. RESMED'S RISK ANALYSIS FOR THESE
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A
DEFECTIVE BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING
INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE
RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE
#: (B)(4).
PERFORMED. THE EVALUATION DETERMINED THAT THE WARNING ALARMS AND DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
(B)(4).
WAS UNABLE TO FULLY CHARGE ITS BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED
DEVICE FAILED TO COMPLETE ITS PRESSURE CALIBRATION TEST. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS PRESSURE CALIBRATION TEST WAS
DUE TO A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
RESMED THAT AN ASTRAL DEVICE DISPLAYED ALARMS. IT WAS ALSO REPORTED THAT THE
VENTILATION DID NOT STOP WHILE IN PATIENT USE. THE PATIENT WAS PLACED ON A BACK-UP
VENTILATOR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE ALARMS WERE DUE
TO A CALIBRATION FAULT. THE DEVICE WAS RECALIBRATED AND SERVICED BEFORE RETURNING
TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
EUR4|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4). NOTE: AT THE TIME
THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING
A NON-REPORTABLE EVENT. THE PRELIMINARY EVALUATION IDENTIFIED NEW INFORMATION TO
A SYSTEM FAULT 74 WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A SOFTWARE TASK ERROR
OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DUE TO A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT FAILED TO COMPLETE ITS
SERVICE CENTER IN BREMEN, GERMANY AND AN EVALUATION WAS PERFORMED. THE EVALUATION
(B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES. THERE WAS NO PATIENT INJURY REPORTED
THAT THE SYSTEM FAULTS WERE DUE TO WATER CONTAMINATION OF THE PNEUMATIC BLOCK AND
INTERNAL BATTERY. THE PNEUMATIC BLOCK AND INTERNAL BATTERY WILL BE REPLACED TO
RESMED (B)(4) THAT A SYSTEM FAULT 180 WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT OCCURRED. DURING THE SERVICE CENTER EVALUATION OF THE DEVICE
LOGS, A BATTERY INOPERABLE ALARM AND TOTAL POWER FAILURE ALARM WERE ALSO OBSERVED.
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 180 AND ALARMS WERE
SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. FURTHER
TECHNICAL EVALUATION DETERMINED THAT THE ALARMS WERE TRIGGERED CORRECTLY DUE TO A
USER ERROR OF LETTING THE BATTERY DEPLETE TO EMPTY. THERE WAS NO FAULT FOUND WITH
THE RETURNED DEVICE. RESMED'S RISK ANAYLSIS FOR THESE FAILURE MODES CONCLUDES THAT
REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE EVALUATION
Malfunction|Increase in Pressure|AUTHORIZED DISTRIBUTOR IN (B)(4) REPORTED A VIVO
50 DEVICE THAT, WHEN NURSE RESPONDED TO AN ALARM, WAS CONFIRMED TO DELIVER A STABLE
INSPIRATION PRESSURE AROUND 27 CMH2O WHICH DID NOT DROP, I.E. NO EXHALATION PHASE
HAD BEEN INITIATED. CIRCUITS AND THE UNIT WERE REPLACED AND THE PROBLEM
DISAPPEARED.|THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF
CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE IN THE USA AND (B)(4). BEING
WHILE THEY WERE SERVICING, AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES. THE
INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)
(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM
FAULTS WERE BOTH SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE
TESTING AT THE (B)(4) SITE. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE.
ACCEPTABLE. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(6) THAT DURING THE
SERVICE CENTER EVALUATION AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-
TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT ALARMS
WERE TRIGGERED ON AN ASTRAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED. A RESMED PRODUCT
SPECIALIST TROUBLESHOT THE DEVICE MALFUNCTION OVER THE PHONE HOWEVER, THE DEVICE
WAS NOT WITH THE CUSTOMER DURING THIS DISCUSSION. RESMED HAS ATTEMPTED MULTIPLE
TIMES TO CONTACT THE CUSTOMER SINCE THE ORIGINAL COMPLAINT HOWEVER NO CALL HAS BEEN
RETURNED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO
Malfunction|No Display / Image;Device Inoperable|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE WAS INOPERABLE AFTER BEING DROPPED. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAILURE WAS DUE TO PHYSICAL DAMAGE TO THE LCD SCREEN AND
PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RESMED (B)(4) THAT A SYSTEM FAULT WAS OBSERVED ON AN ASTRAL DEVICE INDICATING A
POSSIBLE BATTERY ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, A
BATTERY ALARM WAS OBSERVED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT AND BATTERY INOPERABLE
THIS STAGE. (B)(4).
RESMED THAT AN ASTRAL DEVICE DISPLAYED A CRITICALLY LOW BATTERY ALARM RESULTING IN
AN UNEXPECTED RESTART AND POWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED. A RESMED PRODUCT
SPECIALIST TROUBLESHOT THE DEVICE ALARMS OVER THE PHONE. THE EVALUATION DETERMINED
THAT THE ALARMS WERE ALL TRIGGERED AS DESIGNED DUE TO A COMPLETELY DEPLETED
INTERNAL BATTERY. THE CUSTOMER WAS INFORMED OF THIS AND BEGAN CHARGING THE DEVICE
WITH NO FURTHER ISSUES. (B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO
THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN
Malfunction|Battery Problem;Device Stops Intermittently|IT WAS REPORTED TO RESMED
THAT AN ASTRAL DEVICE STOPPED VENTILATING AFTER IT DISPLAYED A RED SCREEN WITH AN
INTERNAL BATTERY FAULT ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR INVESTIGATION.
AN INVESTIGATION WAS PERFORMED BY A BIOMEDICAL TECHNICIAN AT THE RESMED
DISTRIBUTOR. THE INVESTIGATION DETERMINED THAT THE DEVICE WAS WORKING TO
SPECIFICATIONS. THERE WERE NO SYSTEM FAULTS IN THE DEVICE HISTORY LOG, AND NO OTHER
FAULTS WERE OBSERVED. (B)(4).
PERFORMED ON THE RETURNED ASTRAL DEVICE. THE INVESTIGATION DETERMINED THAT THE
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO THE FLOW SENSOR VALUE
OUTSIDE OF IT'S EXPECTED RANGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE
TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS
BEING A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO
INTERNAL SELF-TEST THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) AND AN
COMPLETE ITS OXYGEN FLOW TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
Malfunction|Temperature Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE HAD A DEFECTIVE HEATED FLEX CABLE. THE HEATED FLEX CABLE PREVENTS
CONDENSATION ON THE DEVICE EXPIRATORY VALVE SENSORS. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN PARIS, FRANCE AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE HEATED FLEX CABLE FAULT WAS DUE TO A FAULTY
CONNECTOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES INDICATING AN OUTLET PRESSURE
ISSUE OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT MESSAGES
WERE DUE TO WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A SYSTEM FAULT
74 INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS NOT IN USE WHEN THE
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS DUE TO A SOFTWARE
ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT DURING
A TECHNICAL ANALYSIS OF THE ASTRAL DEVICE, SYSTEM FAULT MESSAGES (SF 180) WERE
OBSERVED INDICATING A BATTERY CHARGER FAULT OCCURRED. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE IS
CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING
WAS NOT DETECTING ITS MAIN POWER SOURCE, HOWEVER, STILL OPERATING WITH ITS INTERNAL
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO RECOGNIZE MAINS WAS
DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
THERE WAS NO PATIENT INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS
5236405|20151023|NOU|Continuous, Ventilator, Home Use|27904|REMOTE ALARM II CABLE 2
M|Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
WAS NOT DETECTING THE 2 METER REMOTE ALARM. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
TIME. RESMED REFERENCE #: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 74) INDICATING A SOFTWARE
TASK ERROR OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION COULD NOT REPRODUCE THE REPORTED
ISSUE. THE DEVICE LOGS AND THERAPY DATA WERE SENT TO THE RESMED DESIGN HOUSE FOR AN
WAS REPORTED TO RESMED (B)(6) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT
MESSAGE (SF 180) INDICATING A BATTERY CHARGER FAULT OCCURRED. DURING THE SERVICE
CENTER EVALUATION OF THE DEVICE LOGS, AN UNEXPECTED RESTART WAS ALSO OBSERVED.
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE
MAIN CIRCUIT BOARD (PCB). RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES
THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 218 AND 148).THERE WAS NO PATIENT
DETERMINED THAT THE SYSTEM FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE
DEVICE. (B)(4)
FAILED TO COMPLETE ITS INTERNAL SELF-TEST.THERE WAS NO PATIENT INJURY REPORTED AS A
RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A HIGH PRESSURE ALARM
RESULTING IN AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO THE MAIN CIRCUIT BOARD (PCB).
ACCEPTABLE. (B)(4).
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO THE MAIN CIRCUIT BOARD (PCB).
ACCEPTABLE. (B)(4).
DETERMINED THAT THE SYSTEM FAULT MESSAGES WERE DUE TO A DEFECTIVE MAIN CIRCUIT
BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
(B)(4)
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A CONTAMINATED PNEUMATIC BLOCK.
RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.
(B)(4)
(B)(4).
RESMED THAT DURING AN INCOMING INSPECTION, AN ASTRAL DEVICE DISPLAYED A BATTERY
INOPERABLE ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED
TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(B)(4)
Malfunction|Inappropriate or Unexpected Reset;Device Displays Incorrect Message;No
Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A
WHITE SCREEN AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULTS WERE DUE TO A DEFECTIVE LCD MODULE. THE TOP CASE ASSEMBLY WAS
REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THESE FAILURE MODES
CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4)
(B)(4).
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74
WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THERE
WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 101 AND SF 218) INDICATING AN
OUTLET PRESSURE ISSUE OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM
FAULT MESSAGES WERE BOTH TRIGGERED CORRECTLY DUE TO A PRESSURE LINE DISCONNECTION
BY THE DEVICE USER. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S
(4).
DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, SYSTEM FAULT MESSAGES (SF
218 AND SF 74) WERE ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
FAULTS WERE DUE TO WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THESE ISSUES.RESMED'S RISK ANAYLSIS FOR THESE FAILURE
MODES CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4)
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM RESULTING
IN AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT
MESSAGE RESULTING IN AN UNEXPECTED RESTART AND POWER FAILURE OF THE DEVICE. THERE
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE ALARMS WERE ALL TRIGGERED AS
DESIGNED DUE TO A COMPLETELY DEPLETED INTERNAL BATTERY. THERE WAS NO FAULT FOUND
WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.
RESMED'S RISK ANAYLSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4)
RESULTING IN AN UNEXPECTED RESTART OF THE DEVICE.THERE WAS NO PATIENT INJURY
DETERMINED THAT THE SINGLE OCCURRENCE DEVICE FAULT WAS DUE TO THE MAIN CIRCUIT
BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK
ANAYLSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4)
DETERMINED THAT THE SINGLE OCCURRENCE HIGH PRESSURE ALARM WAS DUE TO THE MAIN
CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S
(4).
THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, ITS TOUCH SCREEN
WAS INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
THE DISPLAY FAULT WAS DUE TO A DEFECTIVE TOUCH SCREEN. THE TOP CASE ASSEMBLY WAS
REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE
(B)(4)
FAILED TO COMPLETE ITS INTERNAL SELF-TEST.THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION FOUND EVIDENCE OF
WATER INGRESS. THE EVALUATION ALSO DETERMINED THAT THE DEVICE FAILURE TO COMPLETE
ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK
WAS REPLACED TO ADDRESS THIS ISSUE.RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY (B)(6) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE
SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THERE WAS
NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO
THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR
PATIENT USE, IT DISPLAYED A HIGH PRESSURE ALARM RESULTING IN AN UNEXPECTED RESTART
AND POWER FAILURE OF THE DEVICE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO THE MAIN CIRCUIT BOARD (PCB). THE
MAIN PCB WAS REPLACED TO ADDRESS THESE ISSUE. RESMED'S RISK ANAYLSIS FOR THESE
FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4)
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AND SYSTEM
FAULT MESSAGE (SF 180). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE LOGS AND DATA WERE RETURNED TO THE RESMED DESIGN HOUSE FOR AN
EXTENSIVE ENGINEERING INVESTIGATION.THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE.(B)(4)
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED SYSTEM
FAULT 74 WAS NOT CONFIRMED IN THE DEVICE HISTORY LOGS. FURTHER SYSTEM TESTING WAS
UNABLE TO CREATE THE FAULT. THERE WAS NO FAULT FOUND WITH THE RETURNED UNIT.
(B)(4)
THAT AN ASTRAL DEVICE HAD AN INOPERABLE TOUCH SCREEN. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE DISPLAY FAULT WAS DUE TO A DEFECTIVE TOUCH SCREEN. THE
TOP CASE ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR
THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4)
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED. A
RESMED PRODUCT SPECIALIST TROUBLESHOT THE DEVICE ALARM OVER THE PHONE. THE CUSTOMER
WAS INFORMED AND EDUCATED WITH POSSIBLE CAUSES AND REMEDIES OF SYSTEM FAULT 101.
RESMED HAS ATTEMPTED TO CONTACT THE CUSTOMER FOR FURTHER DIAGNOSIS OF THE DEVICE
FAULT BUT HAS BEEN UNABLE TO CONTACT THE CUSTOMER. (B)(4)
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 223) INDICATING A POSITIVE END
EXPIRATORY PRESSURE (PEEP) BLOWER FAILURE OCCURRED. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED. A
RESMED PRODUCT SPECIALIST WENT THROUGH THE TROUBLESHOOTING STEPS WITH THE CUSTOMER.
IT WAS FOUND THAT THE SYSTEM FAULT 223 WAS A SINGLE OCCURRENCE AND COULD NOT BE
REPRODUCED AFTER REBOOT OF THE DEVICE. BASED ON ALL AVAILABLE EVIDENCE, THE SYSTEM
FAULT 223 COULD BE RELATED TO THE PATIENT CIRCUIT NOT BEING FULLY CONNECTED TO THE
DEVICE WHICH WOULD NOT ALLOW THE PRESSURE TO REACH THE DEVICE'S VALUE. RESMED
Malfunction|Device Inoperable;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE WAS BEING SERVICED AT A (B)(6)DISTRIBUTOR WHEN
IT BECAME INOPERABLE. DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS,
SYSTEM FAULTS WERE ALSO OBSERVED. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE (B)(6) CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO AN ASSEMBLY PROBLEM CAUSED DURING THE
DEVICE SERVICING. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
Malfunction|Device Stops Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE STOPPED DELIVERING THERAPY. IT WAS REPORTED THAT THE DEVICE ALARMED
TO WARN THE USER ABOUT THE STOP IN VENTILATION. THE PATIENT WAS PLACED ON A BACK-UP
VENTILATOR WITH NO COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
THAT THE DEVICE FAULTS WERE DUE TO THE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
FRA|Malfunction|Device Displays Incorrect Message;Battery Problem|IT WAS REPORTED
TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A DEFECTIVE BATTERY AND DISPLAYED A
POWER FAILURE ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER FOR
THIS STAGE. (B)(4).
AN ASTRAL DEVICE DISPLAYED AN APNEA ALARM AND "VENTILATION OUT OF ORDER" ERROR
PERFORMED. THE EVALUATION DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE
RETURNED DEVICE. FURTHER EVALUATION FOUND THAT THE APNEA ALARM AND VENTILATION OUT
OF SERVICE MESSAGE WERE TRIGGERED CORRECTLY DUE TO THE DEVICE SETTING OF THE APNEA
VENTILATION MODE CONFIGURED BY THE USER/CAREGIVER. RESMED'S RISK ANALYSIS FOR THESE
Malfunction|Device Displays Incorrect Message;Inappropriate or Unexpected
Reset;Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE
DISPLAYED A HIGH PRESSURE OBSTRUCTION ALARM WHICH CAUSED THE DEVICE TO STOP.
ADDITIONALLY, THE DEVICE ALSO FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS
THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT ((B)(4)) INDICATING A
BATTERY CHARGER FAULT OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER FOR
THIS STAGE. (B)(4).
FRA|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN
RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED
ASTRAL DEVICE STOPPED DELIVERING THERAPY. IT WAS REPORTED THAT THE DEVICE ALARMED
TO WARN THE USER ABOUT THE STOP IN VENTILATION. THE PATIENT WAS PLACED ON A BACK-UP
VENTILATOR WITH NO COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
FOR EVALUATION.THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME OF THE EVENT THE
CAREGIVER HAD TWO RESMED DEVICES. UNFORTUNETLY THE REPORTER WAS UNABLE TO CONFIRM
WHICH DEVICE RELATED TO THE REPORTED FAILURE. BOTH DEVICES WERE RETURNED TO RESMED
FOR EVALUATION. RESMED MEDWATCH 3007573469-2015-00668 ((B)(4)) REFERENCES THE SAME
EVENT. BOTH ARE UNDERGOING AN EXTENSIVE EVALUATION AND A FOLLOW-UP REPORT WILL BE
SENT AFTER THE EVALUATION IS COMPLETED.
Malfunction|Device Displays Incorrect Message;Inappropriate or Unexpected
Reset;Failure to Calibrate|IT WAS REPORTED TO RESMED GERMANY (B)(4) ERROR OCCURRED.
THIS RESULTED IN AN UNEXPECTED RESTART OF THE DEVICE. DURING THE SERVICE CENTER
EVALUATION OF THE DEVICE LOGS, A SELF-TEST FAILURE WAS ALSO OBSERVED. THERE WAS NO
EVALUATION DETERMINED THAT THE SYSTEM FAULT AND UNEXPECTED RESTART WERE BOTH SINGLE
OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. FURTHER TECHNICAL
EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST
WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK
FRA|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED FRANCE THAT WHILE AN
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE
RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
#: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 218). THERE WAS NO PATIENT
DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.RESMED'S
RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE
TO A FAULTY FLOW SENSOR. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES
THAT THE RISK IS ACCEPTABLE.(B)(4)
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD
AN INOPERABLE DISPLAY SCREEN UPON START-UP. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED. A RESMED PRODUCT
SPECIALIST TROUBLESHOT THE DEVICE MALFUNCTION WITH THE CUSTOMER OVER THE PHONE. THE
INOPERABLE SCREEN WAS RECTIFIED AFTER REBOOTING THE DEVICE. (B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 101 AND 218) INDICATING AN
OUTLET PRESSURE ISSUE OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SINGLE
OCCURRENCE DEVICE FAULTS WERE DUE TO A SOFTWARE PROBLEM. THE TECHNICAL EVALUATION
WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. THE DEVICE WAS SERVICED AND RETURNED
RISK IS ACCEPTABLE. (B)(4)
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 101) INDICATING AN OUTLET
PRESSURE ISSUE OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT
ACCEPTABLE. (B)(4).
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A CALIBRATION FAULT. THE DEVICE WAS
RECALIBRATED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THESE FAILURE MODES
WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED SYSTEM
FAULT MESSAGES.THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
THE SYSTEM FAULTS WERE DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB
WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THESE FAILURE MODES
Death|Device Stops Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT ON (B)(6)
2015 AN ASTRAL DEVICE STOPPED DELIVERING THERAPY TO A HOSPITAL PATIENT AND BECAME
INOPERABLE. THE PATIENT WAS THEN PLACED ON A BACK-UP VENTILATOR HOWEVER THEIR
HEALTH CONDITION DID WORSENED. THE PATIENT PASSED AWAY TWO WEEKS LATER ON (B)(6)
2015.|IT WAS REPORTED THAT THE PHYSICIAN DENIED RELEVANCE TO THE DEVICE. THE DEVICE
WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED
Malfunction|No Display / Image;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 AND ITS TOUCH
SCREEN BECAME INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4),
Malfunction|Device Displays Incorrect Message;Battery Problem|IT WAS REPORTED BY
RESMED (B)(4) THAT DURING AN INCOMING INSPECTION, AN ASTRAL DEVICE DISPLAYED A
BATTERY INOPERABLE ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS
STAGE. RESMED REFERENCE #: (B)(4).
WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A SYSTEM
FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS NOT IN USE
WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN BREMEN, GERMANY AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SINGLE OCCURRENCE OF
SYSTEM FAULT 74 WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE'S INTERNAL BATTERY WOULDN'T CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
TIME. (B)(4).
FRA|Malfunction|Device Stops Intermittently;Device Alarm System|IT WAS REPORTED TO
RESMED (B)(6) THAT AN ASTRAL DEVICE ALLEGEDLY FAILED TO TRIGGER A LOW BATTERY
ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT
USE, IT TRIGGERED AN ALARM AND TURNED OFF. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS NOT RETURNED
TO RESMED. THE REPORTING CUSTOMER WAS NOT WITH THE DEVICE AT THE TIME OF THE EVENT
AND THEREFORE COULD NOT PROVIDE DETAIL ON THE ALLEGED TRIGGERED ALARM. A RESMED
PRODUCT SPECIALIST RECOMMENDED THE CUSTOMER VISIT THE PATIENT AND INVESTIGATE THE
DEVICE LOGS TO DETERMINE AND DIAGNOSE THE REPORTED ALARM. THE CUSTOMER COMMUNICATED
UNDERSTANDING AND STATED SHE WOULD CONTACT RESMED IF ADDITIONAL INFORMATION WAS
OBTAINED. RESMED REFERENCE #: (B)(4).
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED DESIGN HOUSE IN (B)(4). THE
INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST
WAS DUE TO A FAULTY NON-RETURN VALVE (NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT
THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED
AS BEING A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S
INTERNAL BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING
FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
Malfunction|Failure to Calibrate;Battery Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. IT WAS ALSO REPORTED THAT
THE DEVICE HAD A DEFECTIVE BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULTS WERE DUE TO WATER DAMAGE OF THE PNEUMATIC BLOCK. RESMED'S RISK
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 147) INDICATING THAT THE PNEUMATIC BLOCK
SOFTWARE DETECTED A STALL IN THE MOTOR. THERE WAS NO PATIENT INJURY REPORTED AS A
(B)(4).
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT'S BATTERY WOULD NOT CHARGE WHEN
CONNECTED TO THE MAINS. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU).
WAS DUE TO THE FLOW SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE. RESMED'S RISK
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE INVESTIGATION
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4) AT THE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 101) INDICATING THAT THE OUTLET
RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT
TIME. RESMED REFERENCE#: (B)(4).
OUTSIDE OF IT'S EXPECTED RANGE. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
DEVICE STOPPED VENTILATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|A PRELIMINARY EVALUATION OF THE EVENT LOGS INDICATES THE DEVICE HAD
SEVERAL ALARMS, PRIOR TO THE VENTILATION STOP, ALERTING THE USER/CAREGIVER OF THE
ISSUE. THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN
EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE NOT
FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
5300505|20151109|NOU|Continuous, Ventilator, Home Use|21335|CIRCUIT SGL CORR HEAT
22MM ASTRL|Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE
AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT'S CIRCUIT TUBING FAILED
TO PROVIDE THE ADEQUEATE PEEP (POSITIVE END EXPIRATORY PRESSURE) VALUE. THE DEVICE
INVOLVEMENT.|THE DEVICE AND CIRCUIT TUBING WERE RETURNED TO THE RESMED DESIGN HOUSE
LOCATED IN SYDNEY, AUSTRALIA FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
Malfunction|Failure to Power Up;No Display / Image|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE HAD A DISPLAY FAILURE AND WAS UNABLE TO POWER ON AFTER A
REBOOT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE REBOOT COULD
NOT BE REPRODUCED AS THE UNIT STARTED UP NORMALLY DURING TESTING. FURTHER
EVALUATION FOUND THAT THE DISPLAY FAILURE WAS DUE TO A SOFTWARE ISSUE. THE DEVICE
WAS SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING
A SOFTWARE TASK ERROR OCCURRED. DURING THE SERVICE CENTER EVALUATION, A SELF-TEST
FAILURE AND POWER FAULT WERE ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED IN (B)(4) FOR AN
RETURN VALVE (NRV). THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO WATER CONTAMINATION OF THE PNEUMATIC
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY. DURING
THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, SYSTEM FAULTS (SF 74 AND 196)
WERE ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR
AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE
Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL WAS
DELIVERING A DIFFERENT PRESSURE THAN THE VALUE THAT WAS SET. THERE WAS NO PATIENT
RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
STAGE. RESMED REFERENCE #: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 218) MESSAGE. THERE WAS NO PATIENT
RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN SYDNEY, AUSTRALIA FOR AN EXTENSIVE
RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED
TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE
DURING A ROUTINE CHECK OF THE ASTRAL DEVICE, IT DISPLAYED A SYSTEM FAULT (SF 74)
INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS NOT IN USE WHEN THE FAULT
EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND COULD
NOT BE REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE
RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
DEVICE'S DISPLAY SCREEN FLICKERED AND BECAME INOPERABLE. THERE WAS NO PATIENT
DETERMINED THAT THE DISPLAY FAULT WAS DUE TO A DEFECTIVE LCD MODULE. THE LCD MODULE
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 101 AND 218) INDICATING THAT THE
OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PATIENT INJURY REPORTED
THAT THE SYSTEM FAULTS WERE BOTH SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE.
THAT THE SYSTEM FAULTS WERE BOTH SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE.
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT'S DISPLAY SCREEN TURNED
BLACK AND WAS INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WOULD
NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING FAULT WAS DUE
TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
(B)(4).
DISPLAYED A BATTERY INOPERABLE ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. AT
THIS STAGE, THERE IS NO FURTHER INFORMATION AVAILABLE. THE REPORTED COMPLAINT COULD
NOT BE CONFIRMED. RESMED REFERENCE #: (B)(4).
WOULD NOT RECOGNIZE THE MAINS POWER SUPPLY UNIT (PSU) WHEN CONNECTED. THERE WAS NO
EVALUATION DETERMINED THAT THE POWER FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT
BOARD (PCB) AND POWER SUPPLY UNIT (PSU). THE MAIN PCB AND PSU WERE REPLACED TO
PERFORMED ON THE RETURNED ASTRAL PNEUMATIC BLOCK. THE INVESTIGATION DETERMINED THAT
PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED(B)(4) THAT
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 218 AND 74). THERE WAS NO PATIENT
TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION METHODS, RESULTS,
5316547|20151125|NOU|Continuous, Ventilator, Home Use|21311|CIRCUIT MONOBRANCHE Ã€
VALVE ASTRAL QUICK CONNECT 22 MM|Malfunction|Pressure Problem|IT WAS REPORTED TO
RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE,
IT'S CIRCUIT TUBING FAILED TO PROVIDE THE ADEQUATE PEEP (POSITIVE END EXPIRATORY
PRESSURE) VALUE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE AND CIRCUIT TUBING WERE RETURNED TO
THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS,
DEVICE HAD AN INOPERABLE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DISPLAY FAULT WAS DUE TO A DEFECTIVE TOUCHSCREEN. THE TOUCHSCREEN WAS REPLACED
THE RISK IS ACCEPTABLE. (B)(4)
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD
INTERMITTENT POWER ISSUES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUES
AS WELL AS REQUESTING THE DEVICE BE RETURNED SO THAT AN ENGINEERING INVESTIGATION
UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
BY RESMED (B)(4) THAT DURING AN INCOMING INSPECTION, AN ASTRAL DEVICE DISPLAYED
SYSTEM FAULTS (SF 74 AND SF 180). DURING THE SERVICE CENTER EVALUATION, A SELF-TEST
FAILURE WAS ALSO OBSERVED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
INTERNAL SELF-TEST.THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
INTERNAL SELF-TEST.THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION.
THE METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE.(B)(4)
DETERMINED THAT THE DEVICE FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE
DEVICE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4)
WAS DETECTING THE MAINS AS AN EXTERNAL POWER SUPPLY. THERE WAS NO PATIENT INJURY
STAGE. (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE WAS DETECTING THE INCORRECT POWER SOURCE. THERE
PERFORMED. THE EVALUATION DETERMINED THAT THE POWER FAULT WAS DUE TO A DEFECTIVE
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 190) INDICATING THAT THE OUTLET PRESSURE
SENSOR FAILED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4)
HOUSE IN (B)(6) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS,
AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE TIMING
ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT
WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT.
THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO
REPORTABLE.
BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4). AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
DEVICE HAD A DISPLAY FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EXTENSIVE EVALUATION WAS UNABLE TO
REPRODUCE THE DISPLAY FAULT, HOWEVER, THE LCD MODULE WAS REPLACED AS A PRECAUTIOUS
MEASURE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE COULD NOT
DETECT THE AC POWER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB) AND A DEFECTIVE INTERNAL BATTERY.
THE MAIN PCB AND INTERNAL BATTERY WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S
RESULT OF THIS INCIDENT.|THE DEVICE LOGS WERE RETURNED TO THE RESMED DESIGN HOUSE
IN SYDNEY, AUSTRALIA FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS,
Malfunction|Failure to Calibrate;Charging Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT FAILED TO
COMPLETE ITS INTERNAL SELF-TEST. IT WAS ALSO REPORTED THAT THE DEVICE WOULD NOT
CHARGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
BLOCK. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE CHARGING FAULT WAS DUE TO A
DEFECTIVE POWER SUPPLY UNIT (PSU). THE PNEUMATIC BLOCK AND PSU WERE REPLACED TO
ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT
(B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED (B)(4) THAT DURING AN
INCOMING INSPECTION, AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
(B)(4).
(B)(4).
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO THE FLOW
SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE. THE PNEUMATIC BLOCK WAS REPLACED TO
(B)(4).
DEVICE'S TOUCHSCREEN WAS INTERMITTENTLY UNRESPONSIVE. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED. THE EXTENSIVE
EVALUATION WAS UNABLE TO REPRODUCE THE DISPLAY FAULT, HOWEVER, THE TOUCH SCREEN WAS
REPLACED AS A PRECAUTIOUS MEASURE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
DEVICE HAD AN INOPERABLE DISPLAY SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS EVALUATED BY RESMED TECHNICAL SERVICE IN
(B)(6). EVALUATION OF THE DEVICE WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. THE
DEVICE WAS OPERATING NORMALLY, HOWEVER, THE TOUCH SCREEN WAS REPLACED AS A
PRECAUTIOUS MEASURE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
(B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AND STOPPED
VENTILATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT COULD NOT
CONFIRMED OR REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE
RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A BATTERY INOPERABLE
ALARM AFTER IT WAS DISCONNECTED FROM THE MAINS. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|PER THE REPORT
PROVIDED TO RESMED BY THE DISTRIBUTOR, THE ALARM WAS DUE TO AN INTERNAL BATTERY
FAULT. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM
THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS A
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. FURTHER
EVALUATION FOUND PHYSICAL DAMAGE TO THE POWER SUPPLY UNIT (PSU). THE PSU WAS
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(6), (B)(6) AND AN
FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULT WAS A SINGLE OCCURRENCE AND COULD NOT BE
ACCEPTABLE. (B)(4).
RECOGNIZE THE POWER SOURCE WHILE CHARGING. THE DEVICE WAS NOT IN USE WHEN THE FAULT
EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 147) ERROR MESSAGE. THERE WAS NO
THE RESMED TECHNICAL SERVICE CENTER IN BREMEN, GERMANY AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO WATER
CONTAMINATION OF THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-
TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED A VERTICAL LINE THROUGH THE LCD MODULE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE TOP CASE COMPONENT. THE TOP
CASE WAS REPLACED TO ADDRESS THIS ISSUE. DURING THE SERVICE CENTER EVALUATION, A
FAULTY PEEP SENSOR WAS ALSO OBSERVED. THE MAIN CIRCUIT BOARD (PCB) WAS REPLACED TO
DEVICE'S EXTERNAL BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
THE DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. RESMED'S RISK ANALYSIS FOR THIS
(B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 188) ERROR MESSAGE. THERE WAS NO PATIENT
TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE METHODS, RESULTS, AND
RECOGNIZE THE POWER SOURCE WHILE CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS
THE DEVICE FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #:(B)(4).
DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE IN (B)
(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND
WAS DUE TO A SOFTWARE TIMING ISSUE OF THE NON-RETURN VALVE (NRV). RESMED'S RISK
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 218) AND BATTERY INOPERABLE ALARM. THERE
PERFORMED. THE EXTENSIVE EVALUATION WAS UNABLE TO REPRODUCE THE BATTERY FAULT,
HOWEVER, THE INTERNAL BATTERY WAS REPLACED AS A PRECAUTIOUS MEASURE. RESMED'S RISK
REFERENCE #: (B)(4). NOTE: THIS IS THE RESUBMISSION OF THE INITIAL SUBMISSION
SUBMITTED ON (B)(6) BUT DUE TO THE SERVER ERROR FROM THE FDA SIDE, THE INITIAL
SUBMISSION WAS NOT SUCCESSFULLY RECEIVED AND PROCESSED ((B)(4)).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 180) WHICH RESULTED IN AN UNEXPECTED
RESTART AND A BATTERY INOPERABLE ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY NON-RETURN
VALVE (NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. (B)(4). AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
VALVE (NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST
ASSESSMENT TO REPORTABLE. NOTE: THIS IS THE RESUBMISSION OF THE INITIAL SUBMISSION
SUBMITTED ON (B)(6) BUT DUE TO THE SERVER ERROR FROM THE FDA SIDE, THE INITIAL
SUBMISSION WAS NOT SUCCESSFULLY RECEIVED AND PROCESSED ((B)(4)).
DURING AN INCOMING INSPECTION, AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE
ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED
PRODUCT SPECIALIST TROUBLESHOT THE DEVICE ISSUE WITH THE CUSTOMER. BASED ON THE
INFORMATION PROVIDED, IT IS POSSIBLE THE BATTERY INOPERABLE ALARM, OBSERVED DURING
INCOMING INSPECTION, WAS CAUSED BY THE PRODUCT BEING SHIPPED WITH AN EMPTY BATTERY.
THE DEVICE WAS REBOOTED TO ADDRESS THIS ISSUE. RESMED REFERENCE #: (B)(4). NOTE:
THIS IS THE RESUBMISSION OF THE INITIAL SUBMISSION SUBMITTED ON (B)(6) BUT DUE TO
THE SERVER ERROR FROM THE FDA SIDE, THE INITIAL SUBMISSION WAS NOT SUCCESSFULLY
RECEIVED AND PROCESSED (REFERENCE TICKET (B)(4).
ACCEPTABLE. (B)(4).
BATTERY WOULD NOT CHARGE COMPLETELY. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS
RETURN VALVE (NRV). THE NRV WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
Malfunction|Failure to Calibrate;Device Displays Incorrect Message;Device Stops
Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A
SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED. THIS RESULTED IN AN
UNEXPECTED RESTART. DURING THE SERVICE CENTER EVALUATION OF THE DEVICE, A SELF-TEST
FAILURE WAS ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS
WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT
BATTERY, ROW|Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE'S EXTERNAL BATTERY WOULD NOT CHARGE COMPLETELY. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. RESMED'S RISK
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE MAIN
THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AFTER A POWER FAILURE
EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY
THE DESIGN FACILITY IN (B)(4). REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCES
OF SYSTEM FAULTS (SF180, SF182) INDICATING BATTERY ISSUES IN THE DEVICE.
PERFORMANCE TESTS WERE NOT ABLE TO REPRODUCE THE REPORTED BATTERY FAULTS. THE
INVESTIGATION DETERMINED THAT THE DEVICE FAULTS WERE MOST LIKELY DUE TO AN
OVERSENSITIVE SOFTWARE DETECTION ISSUE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR
THIS INCIDENT. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED(B)(4) THAT AN ASTRAL
(B)(4).
DEVICE'S INTERNAL BATTERY WAS PREMATURELY DEPLETING AFTER BEING FULLY CHARGED.
PERFORMED. THE EVALUATION DETERMINED THAT THE BATTERY FAULT WAS DUE TO A DEFECTIVE
INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S
ASTRAL DEVICE DISPLAYED A POWER FAILURE ALARM. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR
EVALUATION; THEREFORE, THE REPORTED FAULT COULD NOT BE CONFIRMED. THE DEVICE
SOFTWARE WAS EVALUATED BY RESMED. BASED ON ALL AVAILABLE INFORMATION AND PREVIOUS
INVESTIGATIONS OF SIMILAR COMPLAINTS, THE ROOT CAUSE OF THE REPORTED FAILURE WAS
MOST LIKELY A SOFTWARE ISSUE. (B)(4).
DEVICE DISPLAYED A BLACK SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY
FAULT WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN HOUSE TESTING.
THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS
HAD A FAULTY POWER SUPPLY UNIT (PSU). THERE WAS NO PATIENT INJURY REPORTED AS A
THE POWER FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU). THE PSU WAS
POWER SUPPLY UNIT (PSU) HAD NO OUTPUT VOLTAGE. THERE WAS NO PATIENT INJURY REPORTED
THAT THE POWER FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU). THE PSU WAS
5375610|20160104|NOU|Continuous, Ventilator, Home Use|27001 / 27003 / 27073|ASTRAL
100 - AMER, ASTRAL 150 - AMER|Malfunction|Device Inoperable|ASTRAL DEVICES MAY
EXPERIENCE AN ISSUE WHEN POWERED BY AN EXTERNAL BATTERY (ASTRAL EXTERNAL BATTERY OR
RPS II). THE ISSUE CAN PREVENT THE USER FROM POWERING ON THE DEVICE AFTER THE AUTO
POWER OFF FEATURE POWERS OFF THE DEVICE. THE AUTO-POWER OFF FEATURE OCCURS WHEN
THERE HAS BEEN NO USER INTERACTION WITH THE DEVICE FOR 15 MINUTES AND THE
VENTILATOR IS IN STAND-BY. THIS EVENT CAN ONLY OCCUR AFTER THE DEVICE IS IN STAND-
BY MODE AND DOES NOT OCCUR DURING THERAPY.|THE DESIGN AUTHORITY, (B)(4), HAS
THOROUGHLY INVESTIGATED THE REPORTED EXTERNAL BATTERY ISSUE. THE ROOT CAUSE FOR
THIS FAULT HAS BEEN ISOLATED TO A SOFTWARE DESIGN. RESMED'S RISK ANALYSIS FOR THIS
FAILURE DETERMINED THAT THERE IS A NEGLIGIBLE LIKELIHOOD THAT A PATIENT WILL SUFFER
AN ADVERSE EVENT AS A RESULT OF THIS ISSUE. NO DEVICE WAS INVOLVED IN AN ADVERSE
EVENT. IN RESPONSE TO THIS INVESTIGATION AND IN COMMUNICATION WITH OUR LOCAL RECALL
COORDINATOR AND CDRH, RESMED HAS ISSUED A SAFETY ALERT TO ALL OUR ASTRAL CUSTOMERS
TO ENSURE THEY ARE FULLY AWARE OF THE ISSUE. IN (B)(6) 2015, RESMED RELEASED A NEW
SOFTWARE VERSION FOR ASTRAL DEVICES THAT INCLUDES A CORRECTION TO THIS ISSUE. THIS
CORRECTION WILL BE INCLUDED IN ALL FUTURE SOFTWARE VERSIONS AND SHOULD BE
IMPLEMENTED FOR ALL FIELD DEVICES WITHIN THE TWO-YEAR SERVICE CYCLE OR BEFORE AT
THE CUSTOMER'S PREFERENCE.
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE SENSOR
CIRCUIT BOARD (PCB). THE SENSOR PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S
Malfunction|Battery Problem|IT WAS REPORTED BY RESMED (B)(4) THAT DURING THE
SERVICE CENTER EVALUATION, AN ASTRAL DEVICE WAS NOT RECOGNIZING THE INTERNAL
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE BATTERY FAULT WAS DUE
TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS
ISSUE. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN INOPERABLE BATTERY ALARM
AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
FAULTS WERE DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO ADDRESS THIS
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE POWERED DOWN UNEXPECTEDLY. THE PATIENT
WAS MANUALLY VENTILATED WHILE THE DEVICE WAS CONNECTED TO ANOTHER POWER SOURCE. IT
WAS REPORTED THAT THE BATTERY INDICATION WAS DISPLAYING 10-20% CHARGE AT THE TIME
OF THE EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
EVALUATION WAS PERFORMED. THE PRELIMINARY EVALUATION DETERMINED THAT THE DEVICE
POWER DOWN WAS DUE TO A DEFECTIVE BATTERY AND MAIN CIRCUIT BOARD (PCB). THE BATTERY
AND MAIN PCB WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM. THERE WAS
RESMED TECHNICAL SERVICE CENTER FOR AN EVALUATION. THE DEVICE LOGS WERE SENT TO THE
RESMED INVESTIGATION TEAM FOR AN ENGINEERING INVESTIGATION. THE REPORTED BATTERY
INOPERABLE ALARM WAS CONFIRMED THROUGH REVIEW OF THE DEVICE LOGS AND THE ALARM WAS
NOT REPRODUCABLE AT THE SERVICE CENTER. RESMED HAS INVESTIGATED A SIMILAR COMPLAINT
AND, BASED ON THAT ENGINEERING INVESTIGATION, IT WAS DETERMINED THAT THE REPORTED
FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
(B)(4).
ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS
THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT DISPLAYED A
SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS NOT
IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE
WAS DUE TO A FAULTY NON-RETURN VALVE (NRV). THE PNEUMATIC BLOCK WAS REPLACED TO
(B)(4).
(B)(4).
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY
LOCATED IN (B)(6) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE COMPLAINT
REGARDING AN UNEXPECTED RESTART WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT
THE DEVICE FAULT WAS DUE TO A COMPONENT FAILURE WITHIN THE MAIN CIRCUIT BOARD
(PCB). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
DEVICE'S INTERNAL BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON
THE RETURNED ASTRAL DEVICE AT THE RESMED DESIGN HOUSE LOCATED IN (B)(4). THE
INVESTIGATION DETERMINED THAT THE BATTERY'S FAILURE TO CHARGE WAS DUE TO AN
ISOLATED COMPONENT FAILURE IN THE MAIN PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE
RESULTING IN LOSS OF CONTACT WITH THE POWER SUPPLY. RESMED'S RISK ANALYSIS FOR THIS
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF
75) AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED MANUFACTURING FACILITY LOCATED
IN (B)(6) AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. THE
INVESTIGATION DETERMINED THAT THE SYSTEM FAULT 75 WAS DUE TO A SOFTWARE FAULT
OCCURRING DURING A SUDDEN LOSS OF POWER. RESMED'S RISK ANALYSIS FOR THIS FAILURE
THE RETURNED ASTRAL DEVICE BY RESMED. THE REPORTED SYSTEM FAULT 101 WAS CONFIRMED
THROUGH REVIEW OF THE DEVICE LOGS. THE INVESTIGATION DETERMINED THAT THE SYSTEM
FAULT WAS DUE TO A FAULTY INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT WHILE ASTRAL DEVICE WAS
BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A BLACK SCREEN AND WAS INOPERABLE
WHEN UNPLUGGED FROM MAINS POWER. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION
WAS PERFORMED ON THE RETURNED ASTRAL BATTERY BY RESMED. THE REPORTED COMPLAINT OF A
DEFECTIVE BATTERY WAS CONFIRMED THROUGH THE DEVICE LOGS. THE INVESTIGATION
DETERMINED THAT THE BATTERY FAULT WAS DUE TO AN ISOLATED COMPONENT FAILURE WITHIN
THE BATTERY ASSEMBLY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
ON THE ASTRAL DEVICE BY RESMED. THE REPORTED SYSTEM FAULTS (SF 101 AND 218) WERE
CONFIRMED THROUGH REVIEW OF THE DEVICE DATA LOGS. THE INVESTIGATION DETERMINED THAT
THE FAULTS WERE DUE TO AN INCORRECT CALIBRATION OF THE FLOW SENSOR. THIS CAUSED
DEVICE TO FAIL THE SPECIFIED TOLERANCE RANGE OF THE TEST. RESMED'S RISK ANALYSIS
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT ALARMS
AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING.
THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND
(B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT ALARMS. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR
AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED
THE OCCURRENCES OF SYSTEM FAULTS 74, 195, 196 AND 218. PERFORMANCE TESTING REVEALED
THAT THE DEVICE FAILED TO COMPLETED ITS INTERNAL SELF-TEST. BASED ON ALL AVAILABLE
EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE INVESTIGATION
DETERMINED THAT THE REPORTED SYSTEM FAULTS WERE MOST LIKELY DUE TO A SOFTWARE
ISSUE. THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE
PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
DETECTED DC POWER WHEN CONNECTED TO AC MAINS. THERE WAS NO PATIENT INJURY REPORTED
ON THE RETURNED ASTRAL DEVICE BY RESMED TECHNICAL SERVICE CENTER LOCATED IN (B)(4).
THE RETURNED DEVICE EVALUATION CONFIRMED THAT THE DC POWER WAS DETECTED WHEN IT WAS
CONNECTED TO THE AC MAIN. THE INVESTIGATION DETERMINED THAT THE POWER SUPPLY ISSUE
WAS DUE TO AN ISOLATED COMPONENT FAILURE IN THE MAIN PCB. RESMED RISK ANALYSIS FOR
THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED SERVICE CENTER IN (B)(4). THE
REPORTED SELF-TEST FAILURE COULD NOT BE CONFIRMED HOWEVER, THE INVESTIGATION FOUND
THE DEVICE FLOW SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE. RESMED'S RISK ANALYSIS
(B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER
IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW
RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A
RESMED CLINICAL PRODUCT SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING STEPS
WITH THE RESPIRATORY THERAPIST. THE DEVICE WAS POWER CYCLED AND PLUGGED INTO AC
POWER WITH NO ISSUES. THE RT REPORTED THE DEVICE WAS FUNCTIONING APPROPRIATELY.
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO
RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE
DEVICE LOGS AND PERFORMANCE TESTING CONFIRMED THE OCCURRENCE OF THE REPORTED SYSTEM
FAULT ERROR MESSAGE (SF 65) INDICATING PROGRAM DATA CORRUPTION. THE INVESTIGATION
DETERMINED THAT REPORTED EVENT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS
FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
POWER SUPPLY UNIT (PSU) WAS NOT DELIVERING POWER. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|AN ENGINEERING INVESTIGATION WAS PERFORMED
ON THE RETURNED POWER SUPPLY UNIT. THE INVESTIGATION CONFIRMED THAT THE POWER
SUPPLY UNIT WAS NOT OPERATIONAL DUE TO AN ISOLATED COMPONENT FAILURE. THERE WAS NO
PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. RESMED'S RISK
POWER SUPPLY UNIT (PSU) WAS NOT DELIVERING POWER. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE POWER SUPPLY UNIT (PSU) HAS NOT YET BEEN
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER. BASED ON ALL AVAILABLE EVIDENCE
REPORTED, THE POWER FAULT WAS DUE TO A DEFECTIVE PSU. A REPLACEMENT PSU WAS ISSUED
TO THE CUSTOMER TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED SERVICE CENTER IN (B)(4). THE
ACCEPTABLE. (B)(4). AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULTS RESULTING
IN A POWER DOWN OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
ASTRAL DEVICE BY RESMED. A REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCES OF
SYSTEM FAULT ERROR MESSAGES (SF 82 AND 74) WHICH RESULTED IN A DEVICE POWER FAULT.
THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A FAULTY MAIN CIRCUIT
BOARD (PCB). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
(B)(4).
ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT HAD AN INOPERABLE TOUCH
SCREEN. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE ASTRAL DEVICE TOP CASE ASSEMBLY WAS RETURNED TO THE RESMED
DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. PERFORMANCE TESTING COULD
NOT REPRODUCE THE REPORTED TOUCH SCREEN FAILURE. BASED ON ALL AVAILABLE EVIDENCE
AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT
THE TOUCH SCREEN ISSUE WAS MOST LIKELY DUE TO A POOR CONNECTION BETWEEN THE TOP
CASE ASSEMBLY AND THE DEVICE MAIN CIRCUIT BOARD (PCBA). RESMED'S RISK ANALYSIS FOR
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING
FAULT COULD NOT REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH
THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
DURING A SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A SYSTEM FAULT (SF 74) WAS
IDENTIFIED INDICATING A SOFTWARE TASK ERROR OCCURRED. THERE WAS NO PATIENT INJURY
ACCEPTABLE. (B)(4).
(B)(4).
POWER SUPPLY UNIT (PSU) WOULD NOT DELIVER POWER. THERE WAS NO PATIENT INJURY
DETERMINED THAT DEVICE FAULT WAS DUE TO A DEFECTIVE PSU. THE PSU WAS REPLACED TO
AN ASTRAL DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT DISPLAYED A SYSTEM FAULT
MESSAGE (SF 218). THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4)
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 101) INDICATING THE OUTLET PRESSURE
LYON, FRANCE AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
SYSTEM FAULT 101 WAS DUE TO CONTAMINATION TO THE PNEUMATIC BLOCK, O2 CELL, AND
INSPIRATORY CONNECTOR. FURTHER TECHNICAL EVALUATION FOUND PHYSICAL DAMAGE TO THE
BATTERY COVER. THE CONTAMINATED PARTS AND BATTERY COVER WERE REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES. THERE WAS NO PATIENT INJURY REPORTED
SERVICE CENTER IN (B)(4) AND A PRELIMINARY EVALUATION WAS PERFORMED. THE
PRELIMINARY EVALUATION WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. THE DEVICE
LOGS WERE SENT TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EVALUATION. THE
Malfunction|Device Sensing Problem|IT WAS REPORTED BY RESMED (B)(4) THAT DURING A
SERVICE CENTER EVALUATION OF AN ASTRAL DEVICE, A SENSOR BOARD FAULT WAS FOUND. THE
FAULT WAS DUE TO A FAULTY SENSOR CIRCUIT BOARD (PCB). THE SENSOR PCB WAS REPLACED
THE RISK IS ACCEPTABLE. (B)(4)
(B)(4).
THAT AN ASTRAL DEVICE DISPLAYED A BLACK SCREEN AND WAS INOPERABLE. THERE WAS NO
EVALUATION DETERMINED THAT THE DISPLAY FAILURE WAS DUE TO A DEFECTIVE MAIN CIRCUIT
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF
189) AND RESTARTED UNEXPECTEDLY. THE PATIENT WAS MANUALLY VENTILATED WITH NO
COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS EVALUATED AT THE PATIENT'S HOME BY A RESPIRATORY THERAPIST (RT).
BASED ON THE RT EVALUATION, THEY FEEL THE DEVICE IS FUNCTIONING APPROPRIATELY. PER
THE RT, THE ALLEGED MALFUNCTION MAY HAVE BEEN RELATED TO THE CAREGIVER (NURSE)
CONFIGURATION OF VENTILATION. THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION.
(B)(4).
REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A POWER FAILURE AND DISPLAYED A
SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED. THERE WAS NO
RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 101) INDICATING THE OUTLET PRESSURE
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SINGLE
OCCURRENCE OF SYSTEM FAULT 101 WAS DUE TO A SOFTWARE ISSUE. THE DEVICE WAS
RECALIBRATED AND THE SOFTWARE WAS UPDATED TO ADDRESS THIS ISSUE. RESMED'S RISK
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
TECHNICAL SERVICE CENTER IN (B)(6)AND AN EVALUATION WAS PERFORMED. THE EVALUATION
REPRODUCED DURING IN-HOUSE TESTING. THE THERMISTOR WAS REPLACED AS A PREVENTATIVE
ACTION ALTHOUGH THERE WERE NO FAULTS FOUND WITH THE RETURNED DEVICE. RESMED'S RISK
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM. THERE WAS
EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A SOFTWARE PROBLEM. THE
DEVICE WAS SERVICED AND RECALIBRATED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
(B)(4).
WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT RESTARTED
UNEXPECTEDLY. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
THE UNEXPECTED RESTART WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING
IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS
Malfunction|Device Stops Intermittently;No Display / Image|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "SERVICING REQUIRED" ALARM AND STOPPED
VENTILATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR
THIS STAGE. RESMED REFERENCE #: (B)(4).
REFERENCE #:(B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
(B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM.THERE WAS
STAGE. (B)(4)
INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE,
MANUFACTURING FACILITY LOCATED IN (B)(4) AND AN EXTENSIVE ENGINEERING INVESTIGATION
WAS PERFORMED. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE TIMING ISSUE OF THE NON-RETURN VALVE
(NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE
THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO
RISK IS ACCEPTABLE RESMED REFERENCE #: (B)(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED THAT DURING
A SERVICE CENTER EVALUATION OF THE ASTRAL DEVICE, SYSTEM FAULT MESSAGES WERE
OBSERVED IN THE DEVICE LOG. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN
(B)(4) FOR EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT
Malfunction|No Display / Image;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY AND DISPLAYED A RED
SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
THIS STAGE. RESMED REFERENCE #: (B)(4).
WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT DISPLAYED A SYSTEM
FAULT MESSAGE (SF 191). THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
CENTER IN (B)(6)AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
WHILE THE DEVICE WAS BEING SETUP FOR A DIFFERENT MASK, THE ASTRAL DEVICE DISPLAYED
SYSTEM FAULTS (SF 101 AND SF 218) INDICATING THE OUTLET PRESSURE MEASUREMENT MAY BE
INCORRECT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
RESMED TECHNICAL SUPPORT WENT THROUGH THE TROUBLESHOOTING STEPS AND INFORMED THE
CUSTOMER FOR A SINGLE CIRCUIT WITH LEAK, A DISCONNECTION AND RECONNECTION COULD
TRIGGER THE SYSTEM FAULTS. THE CUSTOMER WAS INFORMED NOT TO SWAP MASKS WHILE THE
DEVICE IS VENTILATING. THE SYSTEM FAULT MESSAGES WERE SINGLE OCCURRENCES DUE TO A
USER ERROR. THE DEVICE IS NOT RETURNING TO RESMED FOR EVALUATION. RESMED REFERENCE
#: (B)(4).
DETERMINED THAT THE DEVICE FAULT WAS DUE TO CONTAMINATION OF THE PNEUMATIC BLOCK.
EUR4|Malfunction|Battery Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE DISPLAYED A BATTERY ALARM INDICATING THAT THE INTERNAL BATTERY COMMUNICATION
WAS LOST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
THIS STAGE. (B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL
DEVICE WAS NOT IN USE BY A PATIENT, IT DISPLAYED AN ERROR MESSAGE AFTER BEING
DISCONNECTED FROM THE EXTERNAL POWER SOURCE. THE DEVICE WAS NOT IN USE WHEN THE
PERFORMED. THE EVALUATION DETERMINED THAT THE POWER FAULT COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING. THE MOST LIKELY ROOT CAUSE OF THIS FAULT WAS A USER ERROR.
THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANAYLSIS FOR THIS
5446476|20160120|NOU|Continuous, Ventilator, Home Use|21311|CIRCUIT SGL S/BORE 22MM
ASTRAL|Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(6) THAT WHILE AN
ASTRAL DEVICE WAS BEING EVALUATED BEFORE PATIENT USE, IT'S CIRCUIT TUBING FAILED TO
PROVIDE THE ADEQUATE PEEP (POSITIVE END EXPIRATORY PRESSURE) VALUE. THE DEVICE WAS
NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|
RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING
INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE,
DEVICE'S INTERNAL BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE
#: (B)(4).
HAD A FAULTY INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
Malfunction|Volume Accuracy Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE WAS DELIVERING THE INCORRECT VOLUME. THERE WAS NO PATIENT INJURY REPORTED AS
THE DEVICE FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
(B)(4).
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE
WAS BEING EVALUATED BEFORE PATIENT USE, IT FAILED TO CHARGE ITS INTERNAL BATTERY.
NOT RETURNED TO RESMED FOR EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT
THROUGH THE TROUBLESHOOTING STEPS WITH THE CUSTOMER AND DETERMINED THAT THE BATTERY
IS DEFECTIVE. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER TO ISSUE A
RETURN OF THE DEVICE FOR FURTHER EVALUATION, HOWEVER, NO CONTACT HAS BEEN MADE. (B)
(4).
DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) ND AN
RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING STEPS AND
ADVISED THE CUSTOMER TO PERFORM A HARD REBOOT AND ASSESS FOR FURTHER BATTERY
ISSUES. THE CUSTOMER STATED SHE WOULD REPLACE THE DEVICE AND EVALUATE THE
VENTILATOR TO DETERMINE IF A REPAIR WILL BE NECESSARY. RESMED HAS ATTEMPTED TO MAKE
CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION REGARDING THE COMPLAINT, HOWEVER,
NO CONTACT HAS BEEN MADE. (B)(4).
DEVICE SHUT DOWN DURING PATIENT TRANSIT. THE PATIENT WAS MANUALLY VENTILATED AND
SWITCHED TO A BACK-UP DEVICE WITH NO COMPLICATIONS. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A CONTAMINATION OF THE PNEUMATIC
ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED (B)(4) THAT AFTER THE
ASTRAL DEVICE IS STOPPED, A CONTINUOUS AUDIBLE ALARM OCCURRED. THERE WAS NO PATIENT
DESIGN FACILITY IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE
DEVICE LOGS CONFIRMED THAT A USING INTERNAL BATTERY ALARM OCCURRED APPROPRIATELY
AND VENTILATION WAS MANUALLY STOPPED. THE INVESTIGATION REVEALED THAT THE USER
DISCONNECTED THE PRESSURE LINE FROM THE VENTILATOR WHICH TRIGGERED THE ALARMS. THE
DEVICE ALARMED AS DESIGNED; THERE WAS NO FAULT FOUND WITH THE RETURNED UNIT. RESMED
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE
WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS MOST
LIKELY DUE TO THE OUTLET FLOW SENSOR, HOWEVER, THE RETURNED ASTRAL WAS NOT IN ITS
ORIGINAL CONDITION UPON ITS ARRIVAL, THEREFORE THE INITIAL CUSTOMER COMPLAINT COULD
NOT BE CONFIRMED. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST
ASTRAL DEVICE WAS BEING TESTED DURING INCOMING INSPECTION, IT FAILED TO COMPLETE
ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
WAS DUE TO A FAULTY PEEP MOTOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS
NOT DELIVERING BREATH DURING NOCTURNAL USE. THE DEVICE WAS NOT IN THE REPORTERS
POSSESSION AS THE TIME OF THIS REPORT. THERE WAS NO PATIENT INJURY REPORTED AS A
ADVISED THE CUSTOMER TO INSPECT THE DEVICE, PERFORM A DATA DOWNLOAD, AND CONTACT
THEM AGAIN TO REVIEW THE INFORMATION. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE
CUSTOMER FOR FURTHER INFORMATION REGARDING THE COMPLAINT, HOWEVER, NO CONTACT HAS
BEEN MADE. (B)(4).
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY PNEUMATIC
BLOCK. THE PNEUMATIC BLOCK WAS RECALIBRATED AND THE DEVICE WAS SERVICED TO ADDRESS
BLOCK. THE PNEUMATIC BLOCK WAS RECALIBRATED AND THE DEVICE WAS SERVICED TO ADDRESS
ACCEPTABLE. (B)(4).
ASTRAL DEVICE WAS BEING TESTING BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS
WAS DUE TO A FAULTY PEEP MOTOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED PRIOR TO PATIENT USE,
IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. DURING THE SERVICE CENTER EVALUATION
A SYSTEM FAULT (SF 223) ERROR MESSAGE WAS ALSO OBSERVED. THE DEVICE WAS NOT IN USE
ENGINEERING INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY PEEP MOTOR. FURTHER
INVESTIGATION DETERMINED THAT IF VENTILATION IS STARTED WITH A DEFECTIVE PEEP
MOTOR, SYSTEM FAULT 223 IS EXPECTED TO BE TRIGGERED. RESMED'S RISK ANALYSIS FOR
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE
5460240|20160119|NOU|Continuous, Ventilator, Home Use|21313|CIRCUIT SGL S/BORE 22MM
ASTR HUM|Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE'S CIRCUIT TUBING FAILED TO PROVIDE THE ADEQUATE PEEP (POSITIVE END
EXPIRATORY PRESSURE) VALUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN
THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)
(4).
DEVICE HAD AN INOPERABLE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED
IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
(B)(4).
ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT'S TOUCHSCREEN WAS INOPERABLE.
PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAULT WAS DUE TO A DEFECTIVE
(B)(4).
Malfunction|Device Displays Incorrect Message;Battery Problem;Inappropriate or
Unexpected Reset|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A
BATTERY INOPERABLE ALARM AND A SYSTEM FAULT 74 RESULTING IN AN UNEXPECTED RESTART
AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE
BY THE RESMED SERVICE CENTER IN (B)(4). REVIEW OF THE DEVICE LOGS CONFIRMED A
SINGLE OCCURRENCE OF SYSTEM FAULT 74 INDICATING SOFTWARE TASK FAILURE AND POWER
FAILURE ALARMS. THE DEVICE EVALUATION DETERMINED THAT THE POWER FAILURE ALARMS WERE
DUE TO A DEFECTIVE INTERNAL BATTERY. THE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
THE DEVICE WAS SERVICE, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
AN ASTRAL DEVICE WAS NOT IN USE BY A PATIENT, IT DISPLAYED A RED SCREEN WITH A
SYSTEM FAULT (SF 190) ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE (B)(6) IN (B)(6).
REVIEW OF THE DEVICE LOG CONFIRMED A SINGLE OCCURRENCE OF SYSTEM FAULT 190 (SF190)
AND PERFORMANCE TESTING ON THE RETURNED DEVICE COULD NOT BE REPRODUCE THE FAULT.
THE INVESTIGATION REVEALED EVIDENCE OF CONTAMINATION IN THE PNEUMATIC BLOCK DUE TO
WATER INGRESS. IT WAS DETERMINED THAT CONTAMINATION OF THE PNEUMATIC BLOCK CAUSED
THE REPORTED SYSTEM FAULT. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS
INCIDENT. (B)(4).
DEVICE DISPLAYED AN AUDIBLE ALARM AND POWERED DOWN. THERE WAS NO PATIENT INJURY
EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING
STEPS AND RECOMMENDED THAT THE CUSTOMER DOWNLOAD THE DEVICE LOG TO DETERMINE THE
EVENTS PRIOR TO THE DEVICE SHUTDOWN. THE CUSTOMER WAS ALSO ADVISED TO ATTEMPT USING
A DIFFERENT POWER SOURCE AS A POSSIBLE CAUSE OF THE ISSUE. RESMED WAS CONTACTED BY
THE CUSTOMER AFTER THE DEVICE LOGS WERE DOWNLOADED AND INFORMED THAT THE EVENTS
SHOWED LOW BATTERY AND BATTERY DEPLETED ALARMS PRIOR TO DEVICE SHUTDOWN. THE POWER
CORD WAS REPLACED BY THE CUSTOMER AND THE DEVICE WAS FUNCTIONING PROPERLY AFTER THE
REPLACEMENT. RESMED REFERENCE #: (B)(4).
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT WHILE A PATIENT WAS
ATTEMPTING TO STOP THERAPY, THE TOUCH SCREEN AND POWER BUTTON WERE UNRESPONSIVE AND
THE DEVICE WOULD NOT STOP THERAPY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED
PRODUCT SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING STEPS AND ADVISED THE
CUSTOMER TO CONTACT ASTRAL SUPPORT WHEN SHE HAD THE DEVICE PRESENT. THE CUSTOMER
INFORMED RESMED THAT SHE WOULD CONTACT US AFTER VISITING THE PATIENT AND DETERMINE
THE CAUSE OF THE ISSUE. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER FOR
FURTHER INFORMATION REGARDING THE COMPLAINT, HOWEVER, NO CONTACT HAS BEEN MADE.
WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED PRIOR TO
OF THE DEVICE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
THE HIGH PRESSURE WARNING ALARM WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE
DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS
FAILED TO CHARGE IT'S INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE CHARGING FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN
WOULD NOT RECOGNIZE THE EXTERNAL POWER SUPPLY. THERE WAS NO PATIENT INJURY REPORTED
THAT THE POWER RECOGNITION FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB).
THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
FRA|Malfunction|Device Displays Incorrect Message;Inappropriate or Unexpected
Reset|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM
FAULT (SF 74) ERROR MESSAGE AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY
FACILITY IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE
LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULT (SF174) IN THE ASTRAL DEVICE. THE
INVESTIGATION DETERMINED THAT THE SYSTEM FAULT WAS DUE TO A SOFTWARE TIMING ISSUE.
THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. RESMED REFERENCE #: (B)(4).
DEVICE'S BATTERY WAS DEPLETING AT A FASTER RATE THAN EXPECTED. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE BATTERY FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK AND
INTERNAL BATTERY. THE PNEUMATIC BLOCK AND INTERNAL BATTERY WERE REPLACED TO ADDRESS
Malfunction|Device Alarm System;Battery Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE HAD A CHARGING RETENTION ISSUE AND WOULD NOT TRIGGER A "CRITICALLY
LOW BATTERY" ALARM PRIOR TO BATTERY DEPLETION. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED
(4).
DEVICE HAD A MOTOR FAULT AND BECAME INOPERABLE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
Malfunction|Failure to Run on Battery;Improper Alarm|HOMECARE PROVIDER IN (B)(6)
REPORTS A PROBLEM WITH A VIVO 50 HOMECARE VENTILATOR, STATING: "THE DEVICE FELL
DOWN BUT WAS PROTECTED IN THE PROTECTIVE CASE. THE PATIENT CLAIMS THAT THE DEVICE
STOPPED WITHOUT ALARMING. HE SAYS THAT IT GOT DAMAGED BECAUSE OF A STICKED OUT
BACTERIA FILTER ON THE OUTLET.." THE REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS
A RESULT OF THE REPORTED EVENT, BUT NO FURTHER INFORMATION IS GIVEN AS TO WHETHER
THE DEVICE ACTUALLY GAVE ANY ALARM. BASED ON THE INFORMATION PROVIDED AT THIS TIME,
INDICATING A POSSIBLE USE ERROR AND WITH NO CONCLUSIVE EVIDENCE AS TO WHETHER THE
DEVICE DID STOP UNEXPECTEDLY OR NOT, THE REPORTED EVENT IS CONSIDERED REPORTABLE
PER 21 CFR PART 803.3.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. BASED UPON THE INFORMATION
THAT BREAS MEDICAL PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE EVENT
IS REPORTABLE UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS AND
GUIDANCE. ACCORDINGLY, IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH
REPORT FOR THIS EVENT.
22MM ASTRL|Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE
AN ASTRAL DEVICE WAS BEING EVALUATED BEFORE PATIENT USE, IT'S CIRCUIT TUBING FAILED
TO PROVIDE THE ADEQUATE PEEP (POSITIVE END EXPIRATORY PRESSURE) VALUE. THE DEVICE
INVOLVEMENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN
THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED
DEVICE'S INTERNAL BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
THE DEVICE CHARGING FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. RESMED'S RISK
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE
WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY COMMUNICATION LOST" ALARM
AND HAD A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE BATTERY
COMMUNICATION ALARM AND SAFETY RESET WERE SINGLE OCCURENCES AND COULD NOT BE
REPRODUCED DURING IN-HOUSE TESTING. THE FAULTS WERE MOST LIKELY DUE TO A SOFTWARE
PROBLEM THAT WAS RESOLVED WITH THE DEVICE RESTARTING. THE DEVICE WAS SERVICED AND
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT ERROR MESSAGES. THERE WAS NO PATIENT INJURY
TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 101 AND SF 218)
INDICATING THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. IT WAS ALSO REPORTED
THAT THE ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO
EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE PNEUMATIC
ASTRAL|Malfunction|Device Sensing Problem;Pressure Problem|IT WAS REPORTED TO
RESMED (B)(6) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTING BEFORE PATIENT USE,
IT'S TRIGGER PRESSURE SENSOR (PTRIG) WAS OUT OF THE DESIGN TOLERANCE. THE DEVICE
INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE
#: (B)(4).
SENSOR CIRCUIT BOARD (PCB). THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ALARM AND POWERED DOWN. THE
PATIENT WAS PLACED ON A BLACK-UP VENTILATOR WITH NO COMPLICATIONS. THERE WAS NO
EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED
RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE RESULTING IN A POWER
DOWN OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS
WERE DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
ADDRESS THIS ISSUE. RESMED REFERENCE #: (B)(4).
PRESSURE MEASUREMENT MAY BE INCORRECT. DURING THE SERVICE CENTER EVALUATION OF THE
DEVICE LOGS, SYSTEM FAULTS 74, AND 218 WERE ALSO OBSERVED. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)
(4).
RESMED THAT AN ASTRAL DEVICE DISPLAYED A RED SCREEN WITH A "VENT INOPERABLE" ALARM.
PERFORMED. DURING THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, "BATTERY
COMMUNICATION LOST" AND "POWER FAILURE" ALARMS WERE OBSERVED. FURTHER TECHNICAL
EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE INTERNAL
BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK
INVESTIGATION. THE ASTRAL DEVICE WAS RETURNED TO A RESMED DISTRIBUTOR LOCATED IN
(B)(4) AND A TECHNICAL EVALUATION WAS PERFORMED. THEIR TECHNICAL EVALUATION
FAULTY NON-RETURN VALVE (NRV). THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ISSUE. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
FAULT (SF 180) INDICATING A BATTERY CHARGER FAULT OCCURRED. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|RESMED
COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS
(B)(4).
SHIROI CITY, (B)(6) AND A TECHNICAL EVALUATION WAS PERFORMED. THEIR TECHNICAL
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
5478078|20160205|NOU|Continuous, Ventilator, Home Use|19623|PNEUMATIC BLOCK ASSY -
ASTRAL|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED
FOR INVESTIGATION. THE ASTRAL DEVICE WAS RETURNED TO A RESMED DISTRIBUTOR LOCATED
IN (B)(4) AND A TECHNICAL EVALUATION WAS PERFORMED. THEIR TECHNICAL EVALUATION
(B)(4).
(B)(4).
SHIROI CITY, (B)(6) AND A TECHNICAL EVALUATION WAS PERFORMED. THEIR TECHNICAL
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
Malfunction|Battery Problem|RESMED SWEDEN REPORTED THAT AN ASTRAL DEVICE WAS
RETURNED FOR A GENERAL EVALUATION. DURING THE EVALUATION IT'S BATTERY WAS FOUND TO
BE DEFECTIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE
THE BATTERY FAULT WAS DUE TO WATER CONTAMINATION. THE INTERNAL BATTERY WAS REPLACED
ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 79 AND SF 189). THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED
TO RESMED FOR INVESTIGATION. A RESMED CLINICAL PRODUCT SUPPORT SPECIALIST HAS
ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION REGARDING THE
COMPLAINT AND DEVICE EVENTS, HOWEVER, NO CONTACT HAS BEEN MADE. RESMED REFERENCE #:
(B)(4).
(B)(4).
DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK AND MAIN
CIRCUIT BOARD (PCB). THE PNEUMATIC BLOCK AND MAIN PCB WERE REPLACED TO ADDRESS THIS
ISSUE. THE DEVICE PASSED ALL SERVICING TESTS AFTER THE REPLACEMENTS. RESMED'S RISK
EXTERNAL POWER SUPPLY UNIT (PSU) WAS DEFECTIVE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|AN ENGINEERING INVESTIGATION WAS PERFORMED
ON THE RETURNED POWER SUPPLY UNIT BY THE DESIGN FACILITY IN (B)(4). THE
INVESTIGATION FOUND THAT THE POWER SUPPLY CABLE WAS DAMAGED DUE TO AN EXCESSIVE
PULLING FORCE. THERE WAS NO PATIENT HARM OR INJURY REPORTED FOR THIS INCIDENT.
RESMED'S RISK ANALYSIS CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED (B)(6)
TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
DEVICE'S BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED (B)(6) FOR AN EXTENSIVE
INTERNAL BATTERY FAILED TO CHARGE CAUSING AN UNEXPECTED RESTART AND A BATTERY
DEPLETION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED PRODUCT SUPPORT
SPECIALIST WENT THROUGH THE TROUBLESHOOTING WITH THE CUSTOMER AND DETERMINED THAT
THE CHARGING FAULT WAS DUE TO A DEFECTIVE POWER CORD. THE CUSTOMER REPLACED THE
POWER CORD TO ADDRESS THIS ISSUE. RESMED REFERENCE #: (B)(4).
RESULT OF THIS INCIDENT.|THE PSU WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
THE PSU WAS DEFECTIVE. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
DEVICE'S INTERNAL BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS
#: (B)(4).
EUR4|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT AN
DEFECTIVE SENSOR CIRCUIT BOARD (PCB). THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
DEVICE'S INTERNAL BATTERY WAS DEPLETING AT A QUICKER PACE THAN NORMAL. THERE WAS NO
EVALUATION COULD NOT REPRODUCE THE BATTERY ISSUE DURING IN-HOUSE TESTING. THE
DEVICE PERFORMED TO SPECIFICATIONS. THERE WAS NO FAULT FOUND WITH THE RETURNED
Malfunction|Device Displays Incorrect Message;Battery Problem;Inappropriate or
Unexpected Reset|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A
BATTERY INOPERABLE ALARM AND RESTARTED UNEXPECTEDLY. THERE WAS NO PATIENT INJURY
EVALUATION. THE ASTRAL DEVICE WAS RETURNED TO A RESMED DISTRIBUTOR'S INTERNAL
SERVICE CENTER FOR EVALUATION. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE
CUSTOMER FOR FURTHER INFORMATION REGARDING THE DEVICE EVALUATION, HOWEVER, NO
CONTACT HAS BEEN MADE. (B)(4).
(B)(4).
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO WATER
ACCEPTABLE (B)(4).
INOPERABLE AFTER THE USER POWERED DOWN THE DEVICE. THERE WAS NO PATIENT INJURY
EVALUATION A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING
STEPS AND ADVISED THE CUSTOMER TO PERFORM A SYSTEM RESET. THE ISSUE WAS RESOLVED
AFTER PERFORMING THE RESET. RESMED REFERENCE #: (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 223) INDICATING A PEEP BLOWER FAILURE
DUE TO A DEFECTIVE PEEP BLOWER. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ALARM INDICATING THE BATTERY
COMMUNICATION WAS LOST. THE DEVICE THEN PERFORMED A SAFETY RESET AND PERFORMED AS
DESIGNED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
ACCEPTABLE. (B)(4).
SERVICE CENTER IN (B)(4). AND AN EVALUATION WAS PERFORMED. THE EVALUATION
ACCEPTABLE. (B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A
POWER SUPPLY ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS
ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER TO ISSUE A RETURN OF THE DEVICE FOR
FURTHER EVALUATION, HOWEVER, NO CONTACT HAS BEEN MADE. RESMED REFERENCE #: (B)(4).
COULD NOT RECOGNIZE THE CORRECT POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE
#: (B)(4).
ACCEPTABLE. (B)(4).
DEFECTIVE INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
ASTRAL BATTERY AT THE RESMED DESIGN HOUSE LOCATED IN (B)(4). THE REPORTED COMPLAINT
OF A DEFECTIVE BATTERY WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT THE BATTERY
FAULT WAS DUE TO AN ISOLATED COMPONENT FAILURE WITHIN THE BATTERY ASSEMBLY.
ASSESSED AS BEING A NON-REPORTABLE EVENT AND WAS CONSIDERED TO BE A DATA ISSUE. THE
FAULT WAS DUE TO AN ISOLATED COMPONENT FAILURE BETWEEN THE MAIN CIRCUIT BOARD (PCB)
AND ATTACHED FLEXES. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS COMPLAINT WAS REPORTED TO
THE MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT AND WAS CONSIDERED
TO BE A DATA ISSUE. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
ASTRAL BATTERY AT THE RESMED (B)(6) LOCATED IN (B)(6). THE REPORTED COMPLAINT OF A
DEFECTIVE BATTERY WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT THE BATTERY
RESMED REFERENCE #: (B)(4). AT THE TIME THIS COMPLAINT WAS REPORTED TO THE
MANUFACTURER IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT AND WAS CONSIDERED TO
BE A DATA ISSUE. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED DESIGN HOUSE IN SYDNEY,
AUSTRALIA. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO THE FLOW SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE.
(B)(4).
Malfunction|Charging Problem;Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE WAS NOT DETECTING TO CORRECT POWER SOURCE. IT WAS ALSO REPORTED THAT
THE BATTERY FAILED TO CHARGE PROPERLY. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|AN ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
POWER SUPPLY UNIT. THE INVESTIGATION CONFIRMED THE REPORTED COMPLAINT AND
DETERMINED THAT THE POWER SUPPLY UNIT WAS NOT OPERATIONAL DUE TO AN ISOLATED
COMPONENT FAILURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT SOUNDED AN ALARM AND BECAME
INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN
HOUSE LOCATED IN SYDNEY, AUSTRALIA FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 191) INDICATING THERE WAS A LOSS OF
COMMUNICATION WITH THE OUTLET FLOW SENSOR. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED
(4).
(B)(4).
22MM ASTRL|Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(6) THAT AN
ASTRAL DEVICE'S CIRCUIT TUBING FAILED TO PROVIDE THE ADEQUATE PEEP (POSITIVE END
EXPIRATORY PRESSURE) VALUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE ASTRAL CIRCUIT TUBING IS CURRENTLY BEING RETURNED TO THE RESMED
RESULT OF THIS INCIDENT.|THE ASTRAL PSU WAS RECEIVED BY THE (B)(6) CENTER IN (B)(6)
AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE REPORTED PSU DEFECT.
THE PSU WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
ASTRAL DEVICE. THE REPORTED SYSTEM FAULT 180 WAS CONFIRMED THROUGH REVIEW OF THE
DEVICE DATA LOGS. THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A
COMPONENT WITHIN THE MAIN CIRCUIT BOARD (PCB). RESMED'S RISK ANALYSIS FOR THIS
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE.
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) CENTER AND
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE STOPPED VENTILATION AND
DISPLAYED A SYSTEM FAULT (SF 101) INDICATING THAT THE OUTLET PRESSURE MEASUREMENT
MAY BE INCORRECT. THE PATIENT WAS MANUALLY VENTILATED AND PLACED ON A BACK-UP
VENTILATOR WITH NO COMPLICATIONS. IT WAS REPORTED THAT AT THE TIME OF THE SYSTEM
FAULT, THE PATIENT WAS BEING MOVED FROM A CHAIR TO A BED, AS WELL AS SWITCHING FROM
A WET CIRCUIT TO A DRY CIRCUIT CONFIGURATION. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN FACILITY
IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE ERROR LOGS
SHOWED A SINGLE OCCURRENCE OF SYSTEM FAULT (SF101) IN THE ASTRAL DEVICE. THE
INVESTIGATION DETERMINED THAT THE SYSTEM FAULT WAS DUE TO THE FLOW SENSOR
MEASUREMENT PROVIDING AN INCORRECT VALUE DUE TO THE PATIENT DISCONNECTED FROM THE
CIRCUIT. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE
REPORTED FAULTY PSU. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
DEVICE LOGS WERE SENT TO THE MANUFACTURING FACILITY IN (B)(4) FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF
SYSTEM FAULT SF 74 INDICATING A SOFTWARE TASK FAULT AND AN INCIDENCE OF AN
UNEXPECTED RESTART. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, THE ROOT
CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE DEVICE LOGS.
INVESTIGATIONS OF SIMILAR COMPLAINTS DETERMINED THAT THIS DEVICE FAULT WAS DUE TO A
SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. RESMED REFERENCE #: (B)(4).
OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED
COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS
SYSTEM FAULT SF 74 INDICATING A SOFTWARE TASK FAULT AND AN INCIDENCE OF AN
UNEXPECTED RESTART. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, THE ROOT
CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE DEVICE LOGS.
INVESTIGATIONS OF SIMILAR COMPLAINTS DETERMINED THAT THIS DEVICE FAULT WAS DUE TO A
INCIDENT. (B)(4).
SYSTEM FAULT SF 74 INDICATING A SOFTWARE TASK FAULT AT THE DEVICE POWER UP. SINCE
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED
COMPLAINT COULD NOT BE DETERMINED FROM THE DEVICE LOGS. INVESTIGATIONS OF SIMILAR
COMPLAINTS DETERMINED THAT THIS DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED'S
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WOULD
NOT CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING INVESTIGATED BY RESMED AND THE
(B)(4).
ACCEPTABLE. (B)(4).
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD
AN INOPERABLE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
WAS DUE TO A FAULTY TOP CASE COMPONENT. THE LCD MODULE WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
DETECT THE CORRECT POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE
TECHNICAL SERVICE CENTER IN SAN DIEGO, CALIFORNIA AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO WATER CONTAMINATION OF
THE PNEUMATIC BLOCK. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT
INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR
Malfunction|Failure to Shut Off|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
WOULD NOT POWER DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED PRODUCT
SUPPORT SPECIALIST WENT THROUGH THE TROUBLESHOOTING STEPS AND ADVISED THE CUSTOMER
TO VISIT THE PATIENT FOR FURTHER EDUCATION AND CLARIFICATION OF USAGE. THE CUSTOMER
STATED THEY WOULD CONTACT RESMED IF THE ISSUE COULD NOT BE ADDRESSED THROUGH
TRAINING. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER FOR FURTHER
INFORMATION REGARDING THE COMPLAINT, HOWEVER, NO CONTACT HAS BEEN MADE. RESMED
DETERMINED THAT THE SYSTEM FAULTS WERE SINGLE OCCURRENCES AND COULD NOT BE
DEVICE. THE PNEUMATIC BLOCK WAS REPLACED AS A PREVENTATIVE ACTION. RESMED'S RISK
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED THAT WHILE AN ASTRAL
DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS INTERNAL
SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A CONTAMINATED
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PCB. THE MAIN PCB WAS REPLACED TO ADDRESS
IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).
DEVICE'S INTERNAL BATTERY WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE
(4).
ASTRAL DEVICE. THE REPORTED SYSTEM FAULT 180 WAS CONFIRMED THROUGH REVIEW OF THE
DEVICE DATA LOGS. THE INVESTIGATION DETERMINED THAT THE BATTERY FAULT WAS DUE TO AN
ISOLATED COMPONENT FAILURE WITHIN THE BATTERY ASSEMBLY. RESMED'S RISK ANALYSIS FOR
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT WHILE A DEVICE WAS IN
A STANDBY MODE AND NOT ON A PATIENT THE ASTRAL DEVICE BECAME INOPERABLE. THERE WAS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT
RETURNED TO RESMED FOR EVALUATION. THE ASTRAL DEVICE WAS RETURNED TO A RESMED
DISTRIBUTOR'S INTERNAL SERVICE CENTER FOR EVALUATION. RESMED HAS ATTEMPTED TO MAKE
CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION REGARDING THE DEVICE EVALUATION,
HOWEVER, NO CONTACT HAS BEEN MADE. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED THAT WHILE THE ASTRAL
DEVICE WAS BEING CONFIGURED FOR THE PATIENT IT FAILED TO COMPLETE ITS INTERNAL
SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
COMPLETE ITS INTERNAL SELF-TEST WAS MOST LIKELY DUE TO THE OUTLET FLOW SENSOR
INSIDE THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED THAT WHILE THE ASTRAL
DEVICE WAS BEING CONFIGURED FOR THE PATIENT IT FAILED TO COMPLETE ITS INTERNAL SELF
COMPLETE ITS INTERNAL SELF-TEST WAS MOST LIKELY DUE TO THE OUTLET FLOW SENSOR
INSIDE THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
CENTER IN LYON AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY PNEUMATIC
ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. NOTE: AT THE
CHANGE THE ASSESSMENT TO REPORTABLE. (B)(4).
A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED SERVICE
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE DEVICE EVALUATION DETERMINED
THAT THE DEVICE'S FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY
A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED SERVICE
THE DEVICE'S FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY
ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. AT THE TIME
A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
ASSESSMENT TO REPORTABLE. (B)(4).
Malfunction|Output Problem|IT WAS REPORTED TO RESMED THAT A PATIENT USING AN ASTRAL
DEVICE WITH SUPPLEMENTAL OXYGEN WAS TAKEN TO THE HOSPITAL FOR LOW SP02 (MEASURED
OXYGEN SATURATION). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED ASSISTED THE CUSTOMER TO TROUBLESHOOT THE ISSUE AND INSTRUCTED THE
CUSTOMER, AS PER THE USER GUIDE, TO PERFORM A LEARN CIRCUIT TEST ON THE DEVICE TO
RECALIBRATE THE OXYGEN FLOW SENSOR. THE DEVICE WAS NOT RETURNED, THEREFORE RESMED
IS UNABLE TO CONFIRM THE REPORTED ISSUE. (B)(4).
DEVICE WAS BEING EVALUATED BY THE CLINICAL STAFF IT DISPLAYED A "BATTERY
INOPERABLE" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED MANUFACTURING FACILITY IN (B)(4)
FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED THE
OCCURRENCE OF SYSTEM FAULTS SF 180 AND SF182 INDICATING THE A BATTERY CHARGER FAULT
AND BATTERY LOST COMMUNICATION WITH THE DEVICE. THESE SYSTEM FAULTS RESULTED IN THE
ALARM BEING TRIGGERED. THE INVESTIGATION DETERMINED THAT THIS DEVICE FAULT WAS DUE
TO A SOFTWARE ISSUE. ALSO THE REVIEW OF THE DEVICE LOGS SHOWED THAT A POWER FAILURE
ALARM WAS TRIGGERED IN THE DEVICE. THE DEVICE INVESTIGATION DETERMINED THAT THE
POWER FAILURE WAS DUE TO A DEPLETED INTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR
Malfunction|Device Sensing Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE HAD A TRIGGER MALFUNCTION DURING VENTILATION SUPPORT INITIATED BY THE
PATIENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE IS CURRENTLY BEING RETURNED TO THE (B)(4) LOCATED IN (B)(4) FOR AN EXTENSIVE
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 137)
ERROR MESSAGE AND WENT THROUGH A POWER CYCLE. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN FACILITY
FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE REPORTED SYSTEM FAULT (SF 137) WAS
CONFIRMED THROUGH A REVIEW OF THE DEVICE DATA LOGS. IN-HOUSE TESTING COULD NOT
REPRODUCE THE FAULT. THE INVESTIGATION DETERMINED THAT THE REPORTED FAULT WAS MOST
LIKELY CAUSED BY A SOFTWARE ISSUE INVOLVING A DELAY IN THE COMMUNICATION BETWEEN
COMPONENTS WITHIN THE DEVICE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED DESIGN HOUSE LOCATED IN (B)
(4). THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL
SELF-TEST WAS DUE TO A SOFTWARE TIMING ISSUE OF THE NON-RETURN VALVE (NRV).
(B)(4).
(B)(4).
THAT THE DEVICE FAULTS WERE DUE TO WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK.
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS
SELF-TEST WAS DUE TO A SOFTWARE TIMING ISSUE OF THE NON-RETURN VALVE (NRV).
RESMED THAT AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM. THERE WAS NO
EVALUATION DETERMINED THAT THE BATTERY INOPERABLE ALARM WAS DUE TO A DEFECTIVE
INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. FURTHER
TECHNICAL EVALUATION FOUND THAT THE DEVICE FAILED TO COMPLETE ITS AIRPATH LEAK
TEST. THE EVALUATION DETERMINED THAT THE LEAK TEST FAILURE WAS DUE TO A DEFECTIVE
(4).
(B)(4).
DEVICE WAS IN STANDBY MODE AND NOT IN USE, THE AUTO-POWER OFF FUNCTION WAS ENABLED
AND THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE POWER
FAULT WAS A SINGLE SOFTWARE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE
SYSTEM TESTING. THE "AUTO POWER OFF" FEATURE POWERS OFF THE DEVICE WHEN THERE HAS
BEEN NO INTERACTION WITH THE DEVICE FOR 15 MINUTES, IT IS USING AN EXTERNAL
BATTERY, AND THE VENTILATOR IS IN STAND-BY MODE. RESMED'S RISK ANALYSIS FOR THIS
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED ITALY THAT WHILE AN
AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO THE MANUFACTURER, IT WAS
SELF-TEST WAS DUE TO A FAULTY NON-RETURN VALVE (NRV). RESMED'S RISK ANAYLSIS FOR
THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME
A NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 101 AND 218) INDICATING THAT THE OUTLET
THE RETURNED ASTRAL DEVICE BY THE RESMED MANUFACTURING FACILITY IN (B)(4). REVIEW
OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULTS 101 AND 218 INDICATING
THE OUTLET PRESSURE MEASUREMENT WAS INCORRECT. PERFORMANCE TESTS WERE NOT ABLE TO
REPRODUCE THE REPORTED SYSTEM FAULT. VISUAL INSPECTION OBSERVED WATER RESIDUE
AROUND THE EXPIRATORY ADAPTER AND WHITE PARTICULATE CONTAMINANTS IN THE ADAPTER
MEMBRANE. MOISTURE AND CONTAMINATION IN THE EXPIRATORY ADAPTER PREVENTED A FULL
SEAL ON THE MEMBRANE RESULTING IN A LEAK AND MAY HAVE CAUSED THE SYSTEM FAULT
ERROR. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
(B)(4).
(B)(4).
Malfunction|Power Problem;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE TRIGGERED AN ALARM AND POWERED DOWN ONCE THE
INTERNAL BATTERY DEPLETED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE LOGS WERE SENT TO THE DESIGN FACILITY LOCATED IN (B)(4) FOR AN
EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS REVEALED THAT A
TOTAL POWER FAILURE HAD OCCURRED IN THE DEVICE. THE REVIEW OF THE BATTERY DATA
DETERMINED THAT THE BATTERY POWER ISSUE WAS DUE TO AN ISOLATED COMPONENT FAILURE
WITHIN THE BATTERY ASSEMBLY. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS
INCIDENT. RESMED REFERENCE #: (B)(4).
(B)(4).
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE RESMED DESIGN
HOUSE LOCATED IN (B)(4). THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE TIMING ISSUE OF THE NON-
RETURN VALVE (NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
RISK IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED
RESULT OF THIS INCIDENT.|THE PSU WAS RECEIVED BY THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE
REPORTED COMPLAINT OF A DEFECTIVE PSU AND FOUND THAT IT WAS DUE TO PHYSICAL DAMAGE.
SERVICE CENTER IN LYON, FRANCE AND AN EVALUATION WAS PERFORMED. THE EVALUATION
(B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 133 AND SF 101). THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING
RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED THAT WHILE AN ASTRAL
Malfunction|Charging Problem;Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE FAILED TO CHARGE ITS BATTERY AND DETECT THE CORRECT POWER SOURCE.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE WAS RETURNED
TO RESMED FOR EVALUATION. PERFORMANCE TESTING CONFIRMED THE REPORTED CHARGING
ISSUE. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATIONS OF SIMILAR COMPLAINTS,
THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS MOST LIKELY DUE TO A SINGLE
COMPONENT FAILURE IN THE MAIN PCB. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS EVENT. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
ASTRAL DEVICE WAS BEING TESTED DURING SERVICING PROCEDURES, IT FAILED TO COMPLETE
ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED;
(B)(4).
ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. REVIEW OF THE DEVICE LOGS SHOWED SINGLE OCCURRENCES OF SYSTEM FAULT
ERROR MESSAGES (SF 74 AND 189) AND A DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF
TEST. PERFORMANCE TESTING COULD NOT REPRODUCE THE DEVICE EVENTS. BASED ON ALL
AVAILABLE EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE
INVESTIGATION DETERMINED THAT THE DEVICE EVENTS WERE DUE TO A SOFTWARE ISSUE.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
WAS REPORTED TO RESMED (B)(4) THAT A PATIENT USING AN ASTRAL DEVICE HAD AN OXYGEN
DESATURATION AFTER THE DEVICE DISPLAYED A SYSTEM FAULT 74 AND PERFORMED A SAFETY
RESET. THE PATIENT WAS MANUALLY VENTILATED WITH NO CONSEQUENCES. THERE WAS NO
RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE
DEVICE LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULT ERROR MESSAGES (SF 74)
FOLLOWED BY SAFETY RESETS. IN-HOUSE TESTING COULD NOT REPRODUCE THE REPORTED DEVICE
FAULTS. BASED ON ALL AVAILABLE EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR
COMPLAINTS, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENTS WERE DUE TO A
INCIDENT. (B)(4).
Malfunction|Power Problem;Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE FAILED TO CHARGE ITS BATTERY AND DETECT THE CORRECT POWER SOURCE.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE WAS RETURNED
TO RESMED FOR EVALUATION. PERFORMANCE TESTING CONFIRMED THE REPORTED CHARGING
ISSUE. PHOTOGRAPHS WERE USED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. BASED ON
THE AVAILABLE INFORMATION AND INVESTIGATIONS OF SIMILAR COMPLAINTS, THE
INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS MOST LIKELY DUE TO A SINGLE
COMPONENT FAILURE IN THE MAIN PCB. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS EVENT. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
(B)(4).
FRA|Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL
DEVICE HAD A POWER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE (B)(6) DESIGN HOUSE LOCATED
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)
(4).
A SOFTWARE TASK ERROR OCCURRED. IT WAS ALSO REPORTED THAT THE DEVICE FAILED TO
COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
FAULTS WERE DUE TO A CONTAMINATED PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THESE
THE RETURNED ASTRAL DEVICE BY THE RESMED SERVICE CENTER IN (B)(4). REVIEW OF THE
DEVICE LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULT 101 INDICATING THE OUTLET
PRESSURE MEASUREMENT WAS INCORRECT. SYSTEM FAULT 101 WAS TRIGGERED IN ASSOCIATION
WITH A CIRCUIT DISCONNECTION EVENT. PERFORMANCE TESTS WERE NOT ABLE TO REPRODUCE
THE REPORTED SYSTEM FAULT. VISUAL INSPECTION OF THE INSPIRATORY FLOW SENSOR SHOWED
TRACES OF HUMIDITY THAT MAY HAVE CAUSED THE SF101 ERROR MESSAGE. RESMED RISK
ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO
A SOFTWARE TASK ERROR OCCURRED. IT WAS ALSO REPORTED THAT THE ASTRAL DEVICE FAILED
TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A
THE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE DEVICE FAILURE TO
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 125) INDICATING THAT THE PROXIMAL
THE SYSTEM FAULT WAS DUE TO A CALIBRATION FAULT OF THE MAIN CIRCUIT BOARD (PCB).
THE DEVICE WAS RECALIBRATED AND SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK
Malfunction|No Audible Alarm;Inappropriate or Unexpected Reset;Device Displays
Incorrect Message|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED
A SYSTEM FAULT (SF 189) ERROR MESSAGE AND PERFORMED A SAFETY RESET. THE REPORTER
STATED THAT THE DEVICE DID NOT TRIGGER AN ALARM PRIOR TO THE FAULT. THERE WAS NO
RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS
CONFIRMED A SINGLE OCCURENCE OF A SYSTEM FAULT (SF 189) AND UNEXPECTED RESTART. THE
REPORTED FAULTS COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE INVESTIGATION
DETERMINED THAT THE DEVICE FAULTS WERE MOST LIKELY DUE TO A SOFTWARE ISSUE. RESMED
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS COULD
NOT CONFIRM THE REPORTED DEVICE SELF-TEST FAILURE AND REVEALED A "QUICK FLOW CHECK"
FAILURE EVENT. BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND THE
AVAILABLE INFORMATION, THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE WAS
MOST LIKELY DUE CONTAMINATION OF THE PNEUMATIC BLOCK OR A SOFTWARE ISSUE. THESE
ISSUES WERE RESOLVED BY REPLACING THE PNEUMATIC BLOCK AND UPGRADING THE DEVICE
SOFTWARE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED DESIGN HOUSE IN (B)(4)
FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE REPORTED SYSTEM FAULT 101 (SF 101)
INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT WAS CONFIRMED. THE
ROOT CAUSE OF THE SYSTEM FAULT 101 WAS DUE TO A FAULTY INSPIRATORY FLOW SENSOR.
RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE
(B)(4).
ASTRAL DEVICE WAS BEING SERVICED BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS
(B)(4).
BATTERY, ROW|Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE COULD NOT DETECT THE CORRECT POWER SOURCE. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE BATTERY FAULT WAS DUE TO A DEFECTIVE EXTERNAL BATTERY.
THE EXTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT ERROR MESSAGE
(SF 137) AND POWERED DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN FACILITY FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. THE REPORTED SYSTEM FAULT (SF137) WAS CONFIRMED THROUGH
A REVIEW OF THE DEVICE DATA LOGS. IN-HOUSE TESTING COULD NOT REPRODUCE THE FAULT.
THE INVESTIGATION DETERMINED THAT THE REPORTED FAULT WAS MOST LIKELY CAUSED BY A
SOFTWARE ISSUE INVOLVING A DELAY IN THE COMMUNICATION BETWEEN COMPONENTS WITHIN THE
DEVICE.RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT.(B)(4).
TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A RED SCREEN AND A "BATTERY
INOPERABLE" ALARM. DURING THE SERVICE CENTER EVALUATION THE DEVICE ALSO FAILED TO
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED TECHNICAL SERVICE CENTER FOR
EVALUATION. IN-HOUSE TESTING WAS UNABLE TO REPRODUCE THE "BATTERY INOPERABLE" ALARM
FAULT. BASED ON THE INFORMATION PROVIDED AND INVESTIGATIONS OF SIMILAR COMPLAINTS,
THE INVESTIGATION DETERMINED THAT THE "BATTERY INOPERABLE" ALARM WAS DUE TO A
HAD A BATTERY ISSUE AND A POWER FAULT OCCURRED. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS
DISPLAYED A "BATTERY INOPERABLE" ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO
WHILE AN ASTRAL DEVICE WAS POWERING UP AND NOT ON A PATIENT, IT SOUNDED AN ALARM.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED. PERFORMANCE TESTING CONFIRMED THE DEVICE BLACK SCREEN
WITH AN ALARM. THE INVESTIGATION DETERMINED THAT REPORTED EVENT WAS MOST LIKELY DUE
TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. (B)(4).
ASTRAL|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE
AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS
PERFORMED ON THE RETURNED ASTRAL DEVICE PNEUMATIC BLOCK. THE INVESTIGATION
COMPONENT FAILURE OR SOFTWARE ERROR IN THE PNEUMATIC BLOCK ASSEMBLY. RESMED'S RISK
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM. THERE
RECEIVED BY THE (B)(6) SERVICE CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE 'BATTERY INOPERABLE' ALARM WAS A SINGLE
OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THERE WAS NO FAULT
FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE
ACCEPTABLE. (B)(4).
TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST
AND EXPERIENCED A POWER-FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
FAULTS WERE SINGLE OCCURENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING.
REVIEW OF THE DEVICE DATA LOGS DETERMINED THE MOST LIKELY ROOT CAUSE OF THE FAULTS
WAS OPERATOR ERROR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT ERROR MESSAGE (SF 189). THERE WAS NO
CONFIRMED A SINGLE OCCURENCE OF A SYSTEM FAULT (SF 189) AND UNEXPECTED RESTART. THE
REPORTED FAULTS COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE INVESTIGATION
DETERMINED THAT THE DEVICE FAULTS WERE MOST LIKELY DUE TO A SOFTWARE ISSUE. RESMED
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE
TIMING ISSUE OF THE NON-RETURN VALVE (NRV). RESMED'S RISK ANALYSIS FOR THIS FAILURE
AS BEING A NON-REPORTABLE EVENT. THE EVALUATION IDENTIFIED NEW INFORMATION TO
(B)(4).
DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT WOULD NOT DETECT THE CORRECT POWER
SOURCE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE (B)(6) HOUSE LOCATED IN (B)
(6)FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION DETERMINED THAT
THE DEVICE FAULT WAS DUE TO A COMPONENT FAILURE ON THE MAIN CIRCUIT BOARD (PCB).
TIMING ISSUE OF THE NON-RETURN VALVE (NRV). THE PNEUMATIC BLOCK WAS REPLACED TO
TIMING ISSUE OF THE NON-RETURN VALVE (NRV). RESMED'S RISK ANAYLSIS FOR THIS FAILURE
ASTRAL|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE
AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT FAILED TO COMPLETE ITS
THERE WAS NO PATIENT INVOLVEMENT.|THE PNEUMATIC BLOCK IS CURRENTLY BEING RETURNED
TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, A SYSTEM FAULT 74 WAS
FOUND IN THE DEVICE DATA LOGS INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE
WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT
INVESTIGATION WAS PERFORMED. A REVIEW OF THE DEVICE LOGS CONFIRMED THE SINGLE
OCCURRENCE OF A SYSTEM FAULT ERROR MESSAGE (SF 74). BASED ON ALL AVAILABLE EVIDENCE
THE REPORTED EVENT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED
CUSTOMER TO PERFORM A HARD REBOOT. THE ISSUE WAS RESOLVED AFTER REBOOTING THE
DEVICE. (B)(4).
PERFORMED. THE EVALUATION DETERMINED THAT THE 'BATTERY INOPERABLE' ALARM WAS A
EVALUATION DETERMINED THAT THE SYSTEM FAULT 137 WAS DUE TO A DEFECTIVE PNEUMATIC
5592175|20160310|NOU|Continuous, Ventilator, Home Use|24925|RESMED POWER STATION II
- JAPAN|Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT A RESMED
POWER STATION FAILED TO CHARGE PROPERLY WHILE BEING USED WITH AN ASTRAL DEVICE.
RETURNED TO THE RESMED DESIGN FACILITY IN (B)(4) FOR AN EXTENSIVE ENGINEERING
INVESTIGATION. THE REPORTED BATTERY CHARGING ISSUE WAS NOT CONFIRMED; POWER SOURCE
TESTING SHOWED THAT THE BATTERY WAS CHARGING. THE INVESTIGATION FOUND NO
ABNORMALITIES WITH THE DEVICE AND THE DEVICE PASSED ALL PERFORMANCE TESTING. RESMED
WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT (B)(4).
WAS DUE TO THE FLOW SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE. THE PNEUMATIC
PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE (B)(6) HOUSE IN (B)(6). THE
RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS
CONFIRMED THE REPORTED SYSTEM FAULTS 143 AND 218. BASED ON ALL AVAILABLE EVIDENCE
AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE REPORTED SYSTEM FAULTS 143
AND 218 WERE DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
(B)(4).
WAS DUE TO THE FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Malfunction|Inappropriate or Unexpected Reset;Battery Problem|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE ALARM WAS TRIGGERED INDICATING A BATTERY ISSUE.
THE BATTERY ALARM RESULTED IN AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO
RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE
DEVICE EVALUATION WAS NOT ABLE TO REPRODUCE THE BATTERY ALARMS AND NO FAULT WAS
FOUND WITH THE BATTERY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. THE
ENGINEERING INVESTIGATION. THE REPORTED BATTERY INOPERABLE ALARM AND RESET EVENT
WERE CONFIRMED THROUGH REVIEW OF THE DEVICE LOGS. THE INVESTIGATION DETERMINED THAT
THE DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
74) INDICATING A SOFTWARE TASK ERROR OCCURRED AND EXPERIENCED A SAFETY RESET. THERE
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 AND SAFETY RESET WERE
SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE
WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE
MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE RESMED'S RISK
ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
Malfunction|Device Alarm System;Device Displays Incorrect Message|IT WAS REPORTED
TO RESMED (B)(4) THAT AN ALARM WAS TRIGGERED ON AN ASTRAL DEVICE INDICATING A
BATTERY ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE OCCURRENCE OF A SYSTEM
FAULT ERROR MESSAGE (SF 218) AND MULTIPLE EXTERNAL BATTERY COMMUNICATION ALARMS.
THE DEVICE EVALUATION SHOWED NO FAULT FOUND WITH THE DEVICE INTERNAL BATTERY. BASED
ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE
INVESTIGATION DETERMINED THAT THE DEVICE EVENTS WERE MOST LIKELY DUE TO A SOFTWARE
ISSUE AND DAMAGE TO THE EXTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT. (B)(4).
74) INDICATING A SOFTWARE TASK ERROR OCCURRED AND EXPERIENCED A SAFETY RESET. THERE
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 AND SAFETY RESET WERE
SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE. RESMED'S RISK
THE DEVICE WAS BEING EVALUATED BY THE CLINICIAN, SYSTEM FAULTS WERE OBSERVED IN THE
ASTRAL DEVICE LOG. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE CUSTOMER STATED THAT THE ASTRAL DEVICE WAS FUNCTIONING NORMALLY BUT
CONTACTED RESMED TECHNICAL SUPPORT WHEN SYSTEM ERRORS WERE FOUND IN THE DEVICE LOG.
RESMED TECHNICAL SUPPORT WAS ABLE TO ASSIST THE CUSTOMER TROUBLESHOOT THE DEVICE.
NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. (B)(4).
AN ASTRAL DEVICE WAS UNABLE TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO
(B)(4)
TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST
AND DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED.
PERFORMED. THE EVALUATION FOUND NO FAULT WITH THE RETURNED DEVICE. THE DEVICE WAS
WHILE THE DEVICE WAS BEING SERVICED, SYSTEM FAULTS WERE OBSERVED IN AN ASTRAL
DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. THE ASTRAL DEVICE WAS RETURNED TO
A RESMED DISTRIBUTOR LOCATED IN (B)(4) AND A TECHNICAL EVALUATION WAS PERFORMED.
THEIR TECHNICAL EVALUATION DETERMINED THAT THE SYSTEM FAULTS WERE SINGLE OCCURENCES
AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE WAS SERVICED AND
74) INDICATING A SOFTWARE TASK ERROR OCCURRED AND PERFORMED A SAFETY RESET. THERE
RECEIVED BY THE RESMED AN INVESTIGATION WAS PERFORMED. THE REPORTED COMPLAINT OF
SYSTEM FAULT 74 WAS CONFIRMED THROUGH REVIEW OF THE DEVICE DATA LOGS. THE
INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A SOFTWARE PROBLEM.
(B)(4).
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES
(SF 74 AND 218) AND PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED
FAULT 74 AND 218 WERE SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-
15MM ASTRL|Malfunction|Pressure Problem;Fracture|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE HAD A FAULTY PRESSURE PORT. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL TUBING WAS RETURNED TO THE RESMED
MANUFACTURING FACILITY IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
INVESTIGATION DETERMINED THAT THE FAULT WAS DUE TO THE INTERNAL TOLERANCE OF THE
PRESSURE PORT. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS COMPLAINT WAS
FAULTS WERE BOTH SINGLE OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE
AN ASTRAL DEVICE PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS
THE DEVICE FAULT WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
RESMED (B)(6) THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY COMMUNICATION LOST"
MESSAGE AND PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AND ASTRAL DEVICE'S
LED LIGHTS INDICATED THE POWER SUPPLY UNIT (PSU) WAS CONNECTED, HOWEVER, THERE WAS
NO VOLTAGE TRANSMITTING TO THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A
THE POWER FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU). THE PSU WAS
(B)(4).
EVALUATION DETERMINED THAT THE SYSTEM FAULT 82 WAS DUE TO A DEFECTIVE MAIN CIRCUIT
(B)(4).
SENSOR CIRCUIT BOARD (PCB) AND NON-RETURN VALVE (NRV). THE PNEUMATIC BLOCK WAS
(B)(4).
Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL
DEVICE WAS BEING TESTED BEFORE PATIENT USE, SUB-OPTIMAL THERAPY WAS BEING DELIVERED
BY THE DEVICE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE
THE DEVICE FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
(B)(4).
THE SYSTEM FAULT 101 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 191) INDICATING THERE WAS A LOSS OF
COMMUNICATION WITH THE OUTLET FLOW SENSOR. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS
CONFIRMED THE REPORTED SYSTEM FAULT ERROR MESSAGE (SF 191). BASED ON PREVIOUS
INVESTIGATIONS OF SIMILAR COMPLAINTS AND ALL AVAILABLE EVIDENCE, THE INVESTIGATION
DETERMINED THAT THE REPORTED EVENT WAS DUE A FAULTY OUTLET FLOW SENSOR. RESMED'S
RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. RESMED REFERENCE #:
(B)(4).
Malfunction|Failure to Calibrate;Power Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE COULD NOT RECOGNIZE IT'S EXTERNAL BATTERY. DURING THE SERVICE
CENTER EVALUATION THE DEVICE ALSO FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE
PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED BATTERY FAULT WAS DUE TO A
COMPLETELY DEPLETED INTERNAL BATTERY. FURTHER EVALUATION DETERMINED THAT THE DEVICE
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY NON-RETURN VALVE
(NRV). THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
Malfunction|Power Problem;Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN
ASTRAL DEVICE WAS DETECTING THE INCORRECT POWER SOURCE AND WOULD NOT CHARGE
PROPERLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE
TO A DEFECTIVE POWER SUPPLY UNIT (PSU) AND MAIN CIRCUIT BOARD (PCB). THE PSU AND
MAIN PCB WERE REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE
FAULT (SF 180) INDICATING A BATTERY CHARGER FAULT OCCURRED. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE
DEVICE WAS RECEIVED BY THE RESMED MANUFACTURING FACILITY IN (B)(4) AND AN EXTENSIVE
ENGINEERING INVESTIGATION WAS PERFORMED. THE INVESTIGATION DETERMINED THAT THE
SYSTEM FAULT 180 WAS DUE TO AN ISOLATED COMPONENT FAILURE OF THE INTERNAL BATTERY.
DEVICE HAD AN INOPERABLE TOUCHSCREEN AND FAILED TO POWER DOWN. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY RESMED. A REVIEW OF
THE DEVICE LOGS COULD NOT CONFIRM THE REPORTED INOPERABLE TOUCHSCREEN AND FAILURE
TO POWER DOWN. IN-HOUSE TESTING COULD NOT REPRODUCE THE REPORTED COMPLAINT. THE
INVESTIGATION RESULTED IN NO FAULT FOUND WITH THE DEVICE. RESMED'S RISK ANALYSIS
INJURY REPORTED AS A RESULT OF THIS INCIDENT. RESMED REFERENCE#: (B)(4).
DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ALARM RESULTING IN A BLACK SCREEN.
RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE REPORTED BLACK
SCREEN ISSUE COULD NOT BE REPRODUCED DURING IN HOUSE TESTING. BASED ON THE
INVESTIGATION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE INVESTIGATION
DETERMINED THAT THE REPORTED ISSUE WAS DUE TO A SOFTWARE ISSUE. RESMED RISK
PATIENT INJURY REPORTED FOR THIS INCIDENT RESMED REFERENCE #: (B)(4).
5648979|20160411|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 - DEU|Death|
Appropriate Term/Code Not Available|IT WAS REPORTED TO RESMED (B)(4) THAT A PATIENT
PASSED AWAY WHILE USING AN ASTRAL DEVICE.|AN EXTENSIVE ENGINEERING INVESTIGATION
WAS PERFORMED ON THE RETURNED ASTRAL DEVICE. AN ANALYSIS OF THE DEVICE DATA LOG DID
NOT SHOW EVIDENCE OF A DEVICE MALFUNCTION. FUNCTIONAL TESTING FOUND THAT THE DEVICE
IS OPERATING WITHIN SPECIFICATIONS. THE INVESTIGATION RESULT IS "NO FAULT FOUND."
BASED ON THE RESULT OF THE DEVICE INVESTIGATION AND THE POLICE INVESTIGATION, NO
RELATIONSHIP WAS FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED EVENT. NOTE: AS
REPORTED IN THE INITIAL MEDWATCH, THE DEVICE WAS QUARANTINED WITH THE (B)(4)
POLICE. THE POLICE CLOSED THE CASE WITH NO CLAIMS MADE AGAINST RESMED. THE DEVICE
WAS THEN PROVIDED TO RESMED. (B)(4).
ACCEPTABLE. (B)(4).
Injury|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT A COPD PATIENT USING
AN ASTRAL DEVICE REQUIRED CAREGIVER ASSISTANCE AFTER THE THERAPY SETTINGS ALLEGEDLY
CHANGED.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
DEVICE BY THE MANUFACTURING FACILITY IN (B)(4). IN-HOUSE TESTING WAS UNABLE TO
REPRODUCE THE REPORTED ISSUE. NO SERIOUS PATIENT INJURY WAS REPORTED. RESMED'S RISK
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED AN ALARM RESULTING IN A BLACK SCREEN. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN MORENO VALLEY, CALIFORNIA AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE USER ALLOWED THE BATTERY TO DEPLETE
CAUSING THE ALARM AND BLACK SCREEN. THE FAILURE MODES COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING AFTER CHARGING THE BATTERY. THERE WAS NO FAULT FOUND WITH
THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT
EUR4|Malfunction|Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ERROR MESSAGE AND FAILED TO
CHARGE PROPERLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED. PERFORMANCE TESTING AND REVIEW OF THE DEVICE LOGS
CONFIRMED THE DEVICE FAILURE TO CHARGE ITS INTERNAL BATTERY. BASED ON PREVIOUS
INVESTIGATIONS OF SIMILAR COMPLAINTS AND ALL AVAILABLE EVIDENCE, THE INVESTIGATION
DETERMINED THAT REPORTED EVENT WAS MOST LIKELY DUE TO AN ISOLATED COMPONENT FAILURE
WITHIN THE DEVICE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS
THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.
RESMED REFERENCE#: (B)(4).
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED
MANUFACTURING FACILITY IN (B)(4) AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO THE FLOW SENSOR VALUE OUTSIDE OF IT'S EXPECTED RANGE.
Malfunction|Battery Problem;Device Displays Incorrect Message|IT WAS REPORTED BY
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS
RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW
OF THE DEVICE DATA LOGS CONFIRMED THE OCCURRENCE OF THE REPORTED BATTERY INOPERABLE
ALARM. THE BATTERY LOGS FOUND THAT THE INTERNAL BATTERY WAS NOT CHARGING. BASED ON
THE INFORMATION AVAILABLE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE
INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS DUE TO AN ISOLATED COMPONENT
FAILURE WITHIN THE BATTERY ASSEMBLY. THE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT. (B)(4).
ASTRAL DEVICE'S INTERNAL BATTERY FAILED TO POWER THE DEVICE AND CHARGE PROPERLY.
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE BATTERY AND CHARGING FAULTS
WERE DUE TO A DEFECTIVE INTERNAL BATTERY AND MAIN CIRCUIT BOARD (PCB). THE INTERNAL
BATTERY AND MAIN PCB WERE REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE RESMED
MANUFACTURING FACILITY IN (B)(4) AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A FAULTY NON-RETURN VALVE (NRV). RESMED'S RISK
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 131) INDICATING THERE WAS A MAIN
BLOWER TEMPERATURE SENSOR FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE
RETURNED ASTRAL DEVICE AT THE RESMED INVESTIGATION SITE. REVIEW OF THE DEVICE DATA
LOGS CONFIRMED THE OCCURENCE OF SYSTEM FAULT 131 WHICH RESULTED IN THE REPORTED
ALARM. IN-HOUSE TESTING WAS NOT ABLE TO REPRODUCE THE FAULT. RESMED'S RISK ANALYSIS
(B)(4).
EVALUATION DETERMINED THAT THE SYSTEM FAULT 75 WAS DUE TO A DEFECTIVE PNEUMATIC
POWER SUPPLY UNIT (PSU) FAILED TO DELIVER POWER. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT (PSU).
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE BOTH SINGLE
OCCURRENCES AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE ROOT CAUSE WAS
DUE TO A SOFTWARE PROBLEM. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.
ACCEPTABLE. (B)(4).
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)./
THE DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO
218) AND PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE OCCURRENCE
OF SYSTEM FAULT 218. PERFORMANCE TESTING ALSO CONFIRMED THAT INTERNAL BATTERY WAS
NOT HOLDING A CHARGE. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS
OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED SYSTEM FAULT
218 WAS DUE TO A SOFTWARE ISSUE. THE REPORTED BATTERY ISSUE WAS DUE TO AN ISOLATED
COMPONENT FAILURE WITHIN THE DEVICE BATTERY ASSEMBLY. RESMED'S RISK ANALYSIS FOR
FAULT (SF 147) ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED;
DETERMINED THAT THE SYSTEM FAULT 147 WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD
(PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
WHILE AN ASTRAL DEVICE WAS POWERING UP, IT DISPLAYED A SYSTEM FAULT (SF 65) ERROR
MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE OCCURENCE OF A SYSTEM
FAULT (SF 65). THE REPORTED FAULT COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING.
THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE.
REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND
AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. PERFORMANCE TESTING COULD NOT
REPRODUCE THE REPORTED SYSTEM FAULT ERROR MESSAGES (SF 65, 133, AND 101). BASED ON
ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE
INVESTIGATION DETERMINED THAT THE REPORTED SYSTEM FAULT ERROR MESSAGES (SF 65, 101,
AND 133) WERE MOST LIKELY DUE TO CONTAMINATION AND A SOFTWARE ISSUE. RESMED'S RISK
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
AN ASTRAL DEVICE HAD A POWER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EVALUATION. A
REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE POWER FAULT. HOWEVER, THE SERVICE
CENTER WAS UNABLE TO REPRODUCE THE FAULT DURING IN-HOUSE TESTING. THE DEVICE MET
THE SERVICE TESTING REQUIREMENTS. THE DEVICE WAS SERVICED, CALIBRATED, TESTED, AND
RETURNED TO THE CUSTOMER. BASED ON THE ENGINEERING REVIEW OF THE DEVICE LOGS,
EVALUATION RESULTS, AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS
NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).
HAD A POWER FAULT AND DEFECTIVE BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
Malfunction|Failure to Calibrate|IT WAS REPORTED BY RESMED ENGLAND THAT WHILE AN
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ALARM AND POWERED
DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
WAS RETURNED TO THE RESMED MANUFACTURING FACILITY IN (B)(4) FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE OCCURRENCE
OF SYSTEM FAULT 182 INDICATING A BATTERY LOSS COMMUNICATION ISSUE. THE
INVESTIGATION DETERMINED THAT THIS DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE. A
REVIEW OF THE DEVICE LOGS SHOWED THAT A POWER FAILURE ALARM WAS TRIGGERED. THE
DEVICE INVESTIGATION DETERMINED THAT THE POWER FAILURE WAS DUE TO A DEPLETED
INTERNAL BATTERY. THERE WAS NO EVIDENCE TO INDICATE THE BATTERY WAS FAULTY.
THE BATTERY INOPERABLE ALARM WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING. THE ROOT CAUSE WAS DUE TO A SOFTWARE PROBLEM. THE DEVICE
RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S
THE SERVICE CENTER EVALUATION OF THE DEVICE LOGS, A SYSTEM FAULT (SF 65) WAS
IDENTIFIED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF
THE DEVICE LOGS CONFIRMED A SINGLE OCCURENCE OF A SYSTEM FAULT (SF 65). THE
REPORTED FAULT COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE INVESTIGATION
DETERMINED THAT THE DEVICE FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED RISK ANALYSIS
INJURY REPORTED FOR THIS INCIDENT (B)(4).
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED
FOR EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE
TROUBLESHOOTING STEPS AND ADVISED THE CUSTOMER TO PERFORM A HARD REBOOT. THE ISSUE
WAS RESOLVED AFTER REBOOTING THE DEVICE. (B)(4).
HAD A BATTERY ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
ASTRAL DEVICE BY RESMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE BATTERY ISSUE. THE
INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO AN ISOLATED COMPONENT
FAILURE OF THE INTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 223) INDICATING A PEEP BLOWER FAILURE
THE SERVICE CENTER EVALUATION, THE ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 75)
ERROR MESSAGE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE
THE SYSTEM FAULT 75 WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS
THE SYSTEM FAULT 101 WAS DUE TO WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK. THE
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS A SINGLE
FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE
ACCEPTABLE. (B)(4).
Malfunction|Pressure Problem|IT WAS REPORTED TO RESMED (B)(4) THAT A PATIENT USING
AN ASTRAL DEVICE HAD AN OXYGEN DESATURATION DUE TO INEFFECTIVE TREATMENT BEING
DELIVERED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE INEFFECTIVE TREATMENT
WAS DUE TO AN INCORRECT PATIENT CIRCUIT SET UP SETTING. THERE WAS NO FAULT FOUND
WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.
(B)(4).
RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED SERVICE
CENTER IN JAPAN AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS
CONFIRMED A SINGLE OCCURRENCE OF SYSTEM FAULT 182 INDICATING BATTERY COMMUNICATION
WAS LOST. SERVICE CENTER IN-HOUSE TESTING WAS NOT ABLE TO REPRODUCE THE REPORTED
BATTERY FAULT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. THE DEVICE
LOGS WERE SENT TO THE MANUFACTURING FACILITY IN SYDNEY, AUSTRALIA FOR A MORE
EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE
OCCURRENCE OF SYSTEM FAULT 182 RESULTING IN THE BATTERY INOPERABLE ALARM. THE
REVIEW ALSO FOUND THAT POWER FAILURE AND DEVICE RESET ALARMS WERE ALSO TRIGGERED.
BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE
ALARMS WERE DUE TO A SOFTWARE ISSUE WITH THE COMMUNICATION INTERFACE BETWEEN THE
PROCESSOR, CHARGER AND INTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT. RESMED REFERENCE #: (B)(4).
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
CENTER FOR EVALUATION. THE EVALUATION COULD NOT REPRODUCE THE "BATTERY INOPERABLE"
ISSUE. THE DEVICE DATA LOGS WERE SENT TO THE RESMED DESIGN HOUSE FOR FURTHER
INVESTIGATION. A SINGLE OCCURENCE OF THE "BATTERY INOPERABLE" ALARM WAS CONFIRMED
THROUGH REVIEW OF THE DEVICE LOGS. BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR
COMPLAINTS, IT WAS DETERMINED THAT FAULT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND
AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. PERFORMANCE TESTING CONFIRMED
THE REPORTED SYSTEM FAULT ERROR MESSAGE (SF 75). BASED ON ALL AVAILABLE EVIDENCE
THE REPORTED EVENT WAS DUE A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
REPORTED AS A RESULT OF THIS INCIDENT. RESMED REFERENCE#: (B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 101 AND 218) INDICATING THAT THE OUTLET
THE RETURNED ASTRAL DEVICE BY RESMED. A REVIEW OF THE DEVICE LOGS CONFIRMED THE
OCCURRENCES OF SYSTEM FAULT ERROR MESSAGES (SF 101 AND 218). BASED ON ALL AVAILABLE
EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE INVESTIGATION
DETERMINED THAT THE REPORTED EVENT WAS DUE TO A FAULTY INSPIRATORY FLOW SENSOR.
Malfunction|Inappropriate or Unexpected Reset|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULT WAS DUE TO A SOFTWARE PROBLEM. THE DEVICE WAS SERVICED AND
RETURNED TO THE CUSTOMER. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES
DEVICE HAD A POWER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. IN-HOUSE TESTING COULD NOT REPRODUCE THE REPORTED POWER FAULT AND THE
REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE INVESTIGATION DETERMINED THAT THE
DEVICE AND THE BATTERY WERE OPERATING TO SPECIFICATION. RESMED'S RISK ANALYSIS FOR
DETERMINED THAT THE SYSTEM FAULT MESSAGES WERE DUE TO WATER CONTAMINATION OF THE
(4).
RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE
ENGINEERING INVESTIGATION WAS PERFORMED. INSPECTION OF THE RETURNED POWER SUPPLY
UNIT (PSU) FOUND THAT THE CODE WAS STRIPPED MOST LIKELY DUE TO PHYSICAL DAMAGE. THE
PSU WAS REPLACED. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
INCIDENT. RESMED REFERENCE#: (B)(4).
ON THE RETURNED ASTRAL DEVICE BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4).
REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULTS 101 AND 218
INDICATING THE OUTLET PRESSURE MEASUREMENT WAS INCORRECT. THE INVESTIGATION
DETERMINED THAT THE CALCULATION OF THE FLOW SENSOR WAS INCORRECT. THIS CAUSED THE
DEVICE TO FAIL THE SPECIFIED TOLERANCE RANGE. RESMED RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED
FOR THIS INCIDENT. RESMED REFERENCE #: (B)(4).
ASTRAL DEVICE DISPLAYED AN ALARM AND HAD A POWER FAILURE. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE BY THE RESMED
MANUFACTURING FACILITY IN (B)(4). REVIEW OF THE DEVICE LOG CONFIRMED THE OCCURRENCE
OF A POWER FAILURE IN THE DEVICE. THE INVESTIGATION DETERMINED THAT THE REPORTED
POWER ISSUE WAS DUE TO AN ISOLATED COMPONENT FAILURE OF THE INTERNAL BATTERY.
CAUSED BY A FAULTY INSPIRATORY FLOW SENSOR. THE DEVICE WAS SERVICED AND RETURNED TO
THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAULT
WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB) AND PNEUMATIC BLOCK CAUSED BY
CONTAMINATION. THE MAIN PCB AND PNEUMATIC BLOCK WERE REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
DEVICE HAD A BATTERY ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE BATTERY WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THERE WAS NO
FAULT FOUND WITH THE RETURNED ASTRAL BATTERY. RESMED'S RISK ANALYSIS FOR THIS
Malfunction|No Display / Image;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A TOUCHSCREEN FAILURE AND DISPLAYED A
SYSTEM FAULT (SF 218) ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED AND AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS
CONFIRMED THE OCCURRENCE OF A SYSTEM FAULT ERROR MESSAGE (SF 218). PERFORMANCE
TESTING CONFIRMED THE REPORTED TOUCHSCREEN FAILURE. BASED ON ALL AVAILABLE EVIDENCE
AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE INVESTIGATION DETERMINED
THAT THE REPORTED SYSTEM FAULT ERROR MESSAGE (SF 218) WAS DUE TO A SOFTWARE ISSUE.
ADDITIONALLY, THE INVESTIGATION DETERMINED THAT THE TOUCHSCREEN FAILURE WAS DUE TO
WATER CONTAMINATION. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. (B)(4).
BY RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE,
IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. DURING THE SERVICE CENTER EVALUATION
OF THE DEVICE DATA LOGS, A SYSTEM FAULT 101 WAS FOUND. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE
OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. FURTHER TECHNICAL
AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT DISPLAYED A SYSTEM FAULT
(SF 74) INDICATING A SOFTWARE TASK ERROR OCCURRED. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS NOT
RETURNED TO RESMED FOR EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH
THE TROUBLESHOOTING STEPS AND ADVISED THE CUSTOMER OF POSSIBLE CAUSES AND REMEDIES
OF SYSTEM FAULT 74. THE CUSTOMER STATED THEY WOULD CONTACT RESMED IF THE ISSUE
COULD NOT BE ADDRESSED THROUGH THE RECOMMENDED TRAINING. RESMED HAS ATTEMPTED TO
MAKE CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION REGARDING THE COMPLAINT,
HOWEVER, NO CONTACT HAS BEEN MADE. RESMED REFERENCE #: (B)(4).
DEVICE FAILED TO RECOGNIZE THE CORRECT POWER SOURCE AND CHARGE IT'S INTERNAL
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE
TO A CONTAMINATED MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS
THESE ISSUES. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE
WAS REPORTED TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE
PATIENT USE, IT DISPLAYED SYSTEM FAULT MESSAGES AND PERFORMED A SAFETY RESET. THE
DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT
INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS AND PERFORMANCE TESTING
CONFIRMED THE REPORTED SYSTEM FAULT ERROR MESSAGES (SF 74 AND 82). THE
INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS DUE AN ISOLATED COMPONENT
FAILURE WITHIN THE DEVICE MAIN CIRCUIT BOARD (PCB). RESMED'S RISK ANALYSIS FOR
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. THE DEVICE WAS NOT IN
USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE, IT HAD AN UNRESPONSIVE
TOUCHSCREEN. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE
THE DISPLAY FAULT WAS DUE TO AN ASSEMBLY PROBLEM WITH THE SCREEN CABLE. THE SCREEN
CABLE WAS REASSEMBLED, AND THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.
(B)(4).
DETERMINED THAT THE SYSTEM FAULT 75 WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD
#: (B)(4).
TOUCHSCREEN WAS FLASHING ON AND OFF. THERE WAS NO PATIENT INJURY REPORTED AS A
RESMED PRODUCT SUPPORT SPECIALIST HAS MADE MULTIPLE ATTEMPTS TO CONTACT WITH THE
CUSTOMER FOR FURTHER INFORMATION REGARDING THE COMPLAINT, HOWEVER, NO CONTACT HAS
BEEN MADE. RESMED REFERENCE #: (B)(4).
AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. A RESMED
CUSTOMER OF POSSIBLE CAUSES AND REMEDIES OF AN INOPERABLE TOUCHSCREEN. THE CUSTOMER
WAS UNABLE TO REPLICATE THE REPORTED FAILURE AND INFORMED RESMED THAT THE FAULT WAS
MOST LIKELY DUE TO A USER ERROR. THE CUSTOMER STATED THEY WOULD CONTACT RESMED IF
THE ISSUE REOCCURRED. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER FOR
FURTHER INFORMATION REGARDING THE COMPLAINT, HOWEVER, NO CONTACT HAS BEEN MADE.
WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE DISPLAYED AN ALARM AND HAD A
POWER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. A REVIEW
OF THE DEVICE LOGS REVEALED SYSTEM FAULT ERROR MESSAGES (SF 75 AND 218) PRIOR TO
VENTILATION, BUT COULD NOT CONFIRM THE REPORTED POWER FAULT DURING VENTILATION.
PERFORMANCE TESTING SHOWED THAT THE DEVICE OPERATED ACCORDING TO SPECIFICATION. THE
INVESTIGATION DETERMINED THAT THE SYSTEM FAULT ERROR MESSAGES WERE DUE TO A
SOFTWARE ISSUE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM AND PERFORMED A
SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION.
REVIEW OF THE DEVICE LOGS CONFIRMED THE SELF-TEST FAILURE AND REVEALED A SINGLE
OCCURENCE OF A SYSTEM FAULT 74 INDICATING A SOFTWARE TASK OCCURED. BASED ON
PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE DEVICE
FAILURE WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Malfunction|No Display / Image;Inappropriate or Unexpected Reset|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED A RED SCREEN AND PERFORMED A SAFETY RESET.
IT WAS ALSO REPORTED THAT THE PATIENT WAS IN THE SHOWER RECEIVING OCCUPATIONAL
THERAPY AT THE TIME OF THE INCIDENT. THERE WAS NO PATIENT INJURY REPORTED AS A
THE DEVICE FAULTS WERE DUE TO A SOFTWARE CALIBRATION ISSUE. THE DEVICE WAS SERVICED
AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
TO RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING TESTED BEFORE PATIENT USE,
IT DISPLAYED A SYSTEM FAULT (SF 65) MESSAGE AND FAILED TO COMPLETE ITS INTERNAL
NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE
ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE OCCURENCE
OF A SYSTEM FAULT (SF 65). THE REPORTED FAULT COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A
SOFTWARE ISSUE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK
IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED FRANCE THAT WHILE AN
PNEUMATIC BLOCK CAUSED BY WATER DAMAGE. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
74) INDICATING A SOFTWARE TASK ERROR OCCURRED AND HAD A POWER FAULT. THERE WAS NO
EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS A SINGLE OCCURRENCE AND WAS DUE
TO A SOFTWARE ISSUE. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE POWER FAULT
WAS DUE TO THE USER ALLOWING THE BATTERY TO DEPLETE COMPLETELY. THE DEVICE WAS
SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE
ASTRAL DEVICE WAS BEING TESTED, IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE
(4), AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 218) ERROR MESSAGE AND PERFORMED A
SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO A
DEFECTIVE MAIN PCB. THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK
ERROR OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
ACCEPTABLE. (B)(4).
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 75 AND 218). THERE WAS NO
EVALUATION DETERMINED THAT THE SYSTEM FAULT WAS MOST LIKELY DUE TO WATER
ACCEPTABLE. (B)(4).
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 218). THIS RESULTED IN AN AUDIBLE
ALARM WHICH NOTIFIED THE USER OF THE FAULT. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM FAULT WAS DUE TO WATER DAMAGE
IN THE PNEUMATIC BLOCK. THE DEVICE WAS SERVICED, CALIBRATED, AND TESTED BEFORE IT
AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 65). THIS RESULTED IN AN AUDIBLE
ALARM WHICH NOTIFIED THE USER OF THE FAULT. THERE WAS NO PATIENT INJURY REPORTED AS
CENTER IN (B)(4) FOR INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE NOT
FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
(B)(4).
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT FAILED TO COMPLETE ITS INTERNAL
NO PATIENT INVOLVEMENT|THE DEVICE WAS RECEIVED BY THE RESMED AND AN EVALUATION WAS
(B)(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 101) ERROR
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE
IS CURRENTLY BEING RETURNED TO THE RESMED MANUFACTURING FACILITY LOCATED IN (B)(4)
DEVICE WAS BEING CONFIGURED FOR PATIENT USE, IT FAILED TO COMPLETE ITS INTERNAL
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM WHEN
DISCONNECTED FROM AC POWER MAIN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE POWER FAULT WAS
DUE TO A DEFECTIVE CONNECTOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS
NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN
FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
SCREEN WAS FROZEN AND UNRESPONSIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
TO RESMED FOR EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE
TROUBLESHOOTING STEPS AND ADVISED THE CUSTOMER OF POSSIBLE CAUSES. THE CUSTOMER WAS
ADVISED TO PERFORM A HARD REBOOT AND THIS RESOLVED THE DISPLAY SCREEN ISSUE. (B)
(4).
PNEUMATIC BLOCK. THE EVALUATION ALSO OBSERVED THAT THE DEVICE SCREEN WAS CRACKED.
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THE CALIBRATION ISSUE. THE DEVICE WAS
REPAIRED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
Malfunction|Power Problem;Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE'S BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE BATTERY
NOT CHARGING WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
DEVICE FAILED TO CALIBRATE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN
FAILURE TO COMPLETE CALIBRATION WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THE CALIBRATION ISSUE. THE DEVICE WAS
ASTRAL DEVICE FAILED TO PASS CALIBRATION. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED SWITZERLAND AND AN
COMPLETE CALIBRATION WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK
WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED, CALIBRATED, AND TESTED
BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT|THE DEVICE WAS RECEIVED BY THE
RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAULT COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING.
ASTRAL DEVICE'S BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE BATTERY WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS NOT
ABLE TO USE AC POWER WHEN PLUGGED INTO THE POWER OUTLET (MAIN). THERE WAS NO
EVALUATION DETERMINED THAT THE POWER ISSUE WAS DUE TO A DEFECTIVE MAIN CIRCUIT
BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT 101 AND 197 ERROR MESSAGES. THERE WAS NO
EVALUATION FOUND CONTAMINATION OF A WHITE POWDERY SUBSTANCE AND WATER INGRESS IN
THE PNEUMATIC BLOCK WHICH MAY HAVE TRIGGERED THE SYSTEM FAULT ERROR MESSAGES. THE
DEVICE WAS REPAIRED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE. (B)(4).
Malfunction|Device Alarm System|AN ASTRAL DEVICE WAS RETURNED TO THE RESMED SERVICE
CENTER IN (B)(4) FOR SERVICE AND EVALUATION DUE TO THE LOW PEEP (END EXPIRATORY
PRESSURE) ALARM KEEPS REOCCURRING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE ASTRAL DEVICE WAS RECEIVED BY THE RESMED SERVICE CENTER IN
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION WAS UNABLE TO REPRODUCE THE
REPORTED ALARM ISSUE. HOWEVER, THE DEVICE FAILED A SAFETY VALVE CHECK DURING
PERFORMANCE TESTING AND THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE
DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
ACCEPTABLE. (B)(4).
5718868|20160511|NOU|Continuous, Ventilator, Home Use|19653|MAIN PCB - ASTRAL 100|
WAS SHOWING A DC INDICATOR EVEN THOUGH THE POWER SUPPLY WAS CONNECTED.THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE MAIN PCB WAS RETURNED TO
THE RESMED INVESTIGATION SITE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
AT THIS STAGE.(B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED (B)(4)
(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED (B)(4) AND
(4).
(4).
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED SERVICE CENTER AND AN
(4).
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY THE RESMED SERVICE
CENTER THAT AN ASTRAL DEVICE THAT WAS RETURNED FOR REPAIR DISPLAYED A SYSTEM FAULT
(SF 65) ERROR MESSAGE AFTER IT WAS POWERED ON AND WOULD NOT RESET. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED BY
THE CUSTOMER'S SERVICE CENTER TO RESMED FOR EVALUATION. THE DEVICE EVALUATION
DETERMINED THAT THE SYSTEM FAULT 65 WAS DUE TO A SOFTWARE ERROR. TO RESOLVE THIS
ISSUE, THE DEVICE SOFTWARE WAS UPGRADED. THE DEVICE WAS CLEANED, SERVICED,
THE RESMED SERVICE CENTER IN (B)(4) FOR EVALUATION. THE METHODS, RESULTS, AND
(4).
Malfunction|Device Operational Issue|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE WILL NOT POWER OFF. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED;
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE CUSTOMER CONTACTED RESMED
TECHNICAL SUPPORT TO REQUEST ASSISTANCE REGARDING A POWER ISSUE WHERE THE DEVICE
WILL NOT POWER OFF. THE TECHNICAL SUPPORT REPRESENTATIVE WENT THROUGH THE
TROUBLESHOOTING STEPS WITH THE CUSTOMER AND REQUESTED THE DEVICE TO BE REBOOTED AND
THIS RESOLVED THE ISSUE. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. (B)
(4).
LOANER DEVICE WILL NOT TURN OFF, THE SCREEN WAS STUCK ON THE LOGO AND ALARMED.
RETURNED TO THE RESMED SERVICE CENTER IN (B)(4) FOR EVALUATION. THE DEVICE
EVALUATION WAS UNABLE TO REPLICATE THE REPORTED ISSUE OF THE SCREEN STUCK ON THE
LOGO. IT WAS ALSO OBSERVED THAT THE DEVICE BATTERY WAS CRITICALLY LOW. THE DEVICE
PASSED PERFORMANCE TESTING AFTER IT WAS SERVICED, SOFTWARE UPGRADED, AND
CALIBRATED. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE
ACCEPTABLE. (B)(4).
PNEUMATIC BLOCK. DURING EVALUATION, IT WAS ALSO OBSERVED THAT THE BATTERY WAS
DEPLETED. TO ADDRESS THESE ISSUES, THE PNEUMATIC BLOCK AND THE BATTERY WERE
REPLACED. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS
BY RESMED (B)(4) THAT WHILE AN ASTRAL DEVICE WAS BEING SERVICED, IT FAILED TO
COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED;
RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING USED FOR TRAINING PURPOSES, IT
DISPLAYED A BATTERY INOPERABLE ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|RESMED HAS REQUESTED FOR THE
DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE
ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
THE RESMED MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING
THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE THE PRESSURE
SENSOR WAS OUTSIDE OF ITS EXPECTED RANGE. THE DEVICE WAS SERVICED AND RETURNED TO
ASTRAL DEVICE WAS BEING SERVICED, IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE
FAULTY PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF74) ERROR MESSAGE INDICATING A
SOFTWARE TASK FAULT. DURING THE SERVICE CENTER EVALUATION, A SELF-TEST FAILURE WAS
ALSO OBSERVED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT WATER INGRESS IN THE
PNEUMATIC BLOCK TRIGGERED THE SYSTEM FAULT ERROR MESSAGE. THE DEVICE WAS SERVICED,
Malfunction|Power Problem|IT WAS REPORTED BY RESMED (B)(4) THAT AN ASTRAL DEVICE'S
POWER SUPPLY CABLE WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
THE POWER SUPPLY CABLE WAS BROKEN AND WAS NOT PROVIDING POWER TO THE DEVICE. THE
POWER SUPPLY CABLE WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND
(B)(4).
DEVICE DID NOT TRIGGER A "CRITICALLY LOW BATTERY" ALARM PRIOR TO BATTERY DEPLETION.
THE PATIENT WAS PLACED ON A BACK-UP VENTILATOR WITH NO CONSEQUENCES. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE AT THE INVESTIGATION SITE
IN (B)(4). THE INVESTIGATION DETERMINED THAT THE DEVICE FAULT WAS DUE TO AN
ISOLATED COMPONENT FAILURE OF THE INTERNAL BATTERY. THE INTERNAL BATTERY WAS
TIME THIS COMPLAINT WAS REPORTED TO THE MANUFACTURER IT WAS ASSESSED AS BEING A
NON-REPORTABLE EVENT. THE INVESTIGATION IDENTIFIED NEW INFORMATION TO CHANGE THE
IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE
IT DISPLAYED SYSTEM FAULT MESSAGES, AND FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED MANUFACTURING
(4).
Malfunction|No Display / Image;Failure to Calibrate|IT WAS REPORTED TO RESMED (B)
(4) THAT AN ASTRAL DEVICE HAD A DISPLAY FAILURE AND FAILED TO COMPLETE ITS INTERNAL
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAILURE WAS
DUE TO A DEFECTIVE TOP CASE COMPONENT. THE TOP CASE COMPONENT WAS REPLACED TO
ADDRESS THIS ISSUE. FURTHER TECHNICAL EVALUATION DETERMINED THAT THE DEVICE FAILURE
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT WHILE AN ASTRAL
DEVICE WAS NOT VENTILATING ON A PATIENT, IT HAD A DISPLAY FAILURE. THE DEVICE WAS
NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|
TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S
DEVICE'S BATTERY DID NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED
BATTERY ISSUE WAS DUE TO A FAULTY MAIN PRINTED CIRCUIT BOARD (PCB). THE MAIN PCB
WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST DURING SET-UP. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS
RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR GENERAL SERVICE AND
EVALUATION. DURING EVALUATION, THE DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST
DUE TO A FAULTY PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
ISSUE. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF188) ERROR MESSAGE. THE DEVICE WAS NOT
USED ON A PATIENT WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT
INVOLVEMENT.|THE ASTRAL DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
SYSTEM FAULT (SF188) ERROR MESSAGE DUE TO A FAULTY PNEUMATIC BLOCK. THE PNEUMATIC
BLOCK WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND RETURNED TO
Malfunction|Battery Problem;Device Alarm System|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE HAD A CHARGING RETENTION ISSUE AND WOULD NOT TRIGGER A
"CRITICALLY LOW BATTERY" ALARM PRIOR TO BATTERY DEPLETION. THERE WAS NO PATIENT
RETURNED TO THE RESMED INVESTIGATION SITE LOCATED IN (B)(4), FOR AN EXTENSIVE
ASTRAL DEVICE PERFORMED A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A
EDUCATED THE CUSTOMER WITH ALARM DYNAMICS OF SWAPPING TO THE INTERNAL BATTERY. THE
CUSTOMER STATED THAT THE ISSUE WAS MOST LIKELY DUE TO A USER ERROR WHEN THE PATIENT
ALLOWED THE DEVICE TO DEPLETE COMPLETELY. RESMED REFERENCE #: (B)(4).
IT DISPLAYED A SYSTEM FAULT (SF 218), AND FAILED TO COMPLETE ITS INTERNAL SELF-
TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. FURTHER TECHNICAL
NOT BE REPRODUCED DURING IN-HOUSE TESTING. RESMED'S RISK ANALYSIS FOR THESE FAILURE
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE BATTERY IN
AN ASTRAL DEVICE IS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS SENT TO THE RESMED TECHNICAL SERVICE CENTER IN (B)
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN
THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS
REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND
TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE
FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE RESMED REFERENCE #: (B)(4).
WATER INGRESS IN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS
THAT THE RISK IS ACCEPTABLE RESMED REFERENCE #: (B)(4).
ACCEPTABLE RESMED REFERENCE #: (B)(4).
A SYSTEM FAULT (SF74) INDICATING A SOFTWARE TASK ERROR MESSAGE WAS DISPLAYED IN AN
ASTRAL DEVICE. THIS CAUSED THE ASTRAL DEVICE TO PERFORM A SAFETY RESET. THERE WAS
THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW
OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM
FAULT 74 WAS TRIGGERED IN THE DEVICE. THE SYSTEM TESTING PERFORMED BY TECHNICAL
SERVICES COULD NOT REPRODUCE THE FAULT. THE DEVICE WAS SERVICED, CLEANED,
CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE #:
(B)(4).
RESMED THAT A "BATTERY INOPERABLE" ALARM WAS TRIGGERED IN AN ASTRAL DEVICE. THERE
PERFORMED. THE EVALUATION DETERMINED THAT THE 'BATTERY INOPERABLE' ALARM WAS A
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING; THE RESULT
WAS "NO FAULT FOUND." THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED
BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE
MODES CONCLUDES THAT THE RISK IS ACCEPTABLE (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 101) INDICATING THAT THE OUTLET PRESSURE
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4).
A REVIEW OF THE DOWNLOADED DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF
SYSTEM FAULT 101 WAS TRIGGERED IN THE DEVICE. THE SYSTEM TESTING PERFORMED BY
TECHNICAL SERVICES COULD NOT REPRODUCE THE FAULT. THE EVALUATION ALSO FOUND DRIED
SOLUTION CONTAMINANT ON THE TOP CASE OF THE DEVICE AND THE EXPIRATORY FLOW SENSOR.
IT WAS DETERMINED THAT THE CAUSE OF THE SYSTEM FAULT WAS DEVICE CONTAMINATION.
(B)(4).
TOUCH SCREEN WAS FREEZING AND NO DISPLAY WAS COMING UP. THE DEVICE WAS NOT IN USE
WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION.
VISUAL INSPECTION OF THE DEVICE UPON RECEIPT FOUND INSECT INFESTATION IN THE CARRY
BAG AND IN THE DEVICE. NO PERFORMANCE EVALUATION HAS BEEN PERFORMED DUE TO THE
INSECT CONTAMINATION. RESMED REFERENCE #: (B)(4).
ACCEPTABLE. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED ENGLAND THAT AN ASTRAL
ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 148) MESSAGE. THE DEVICE WAS NOT IN USE
WAS RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4). A REVIEW OF THE DOWNLOADED
DEVICE EVENTS LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 148 WAS
TRIGGERED IN THE DEVICE. THE EVALUATION ALSO FOUND THAT THE DEVICE FAILED TO
COMPLETE ITS INTERNAL SELF-TEST. IT WAS DETERMINED THAT THE CAUSE OF THE SYSTEM
FAULT AND THE SELF-TEST FAILURE WAS DUE TO CALCIUM DEPOSIT CONTAMINATION IN THE
PNEUMATIC BLOCK DUE TO WATER INGRESS. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 65) ERROR MESSAGE. THE DEVICE WAS NOT IN
WAS PERFORMED. ON POWER UP, THE ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 65,
THEREFORE, THE REPORTED ISSUE WAS CONFIRMED. THE EVALUATION FOUND THAT THE SOFTWARE
IN THE PNEUMATIC BLOCK NEEDS TO BE RECALIBRATED. THE DEVICE WAS SERVICED,
CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS
DETECTING THE INCORRECT POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES
IN (B)(6) AND AN EVALUATION WAS PERFORMED. THE EVALUATION FOUND THAT THE DEVICE WAS
NOT CHARGING WHEN CONNECTED TO THE AC POWER. IT WAS DETERMINED THAT THE CAUSE OF
THE POWER ISSUE WAS A FAULTY MAIN PRINTED CIRCUIT BOARD (PCB). THE PCB WAS REPLACED
TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE POWER SUPPLY IN
AN ASTRAL DEVICE WAS NOT PROVIDING POWER. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE POWER SUPPLY WAS
RETURNED TO THE RESMED TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE POWER SUPPLY WAS DEFECTIVE. THE
CUSTOMER WAS GIVEN A REPLACEMENT POWER SUPPLY TO ADDRESS THE ISSUE. RESMED'S RISK
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 75) ERROR MESSAGE. THE DEVICE WAS NOT IN
WAS PERFORMED. THE EVALUATION FOUND THAT THE SOFTWARE IN THE PNEUMATIC BLOCK NEEDS
TO BE RECALIBRATED. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS
TECHNICAL SERVICES IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE
DOWNLOADED DEVICE EVENTS LOG CONFIRMED THAT THE OCCURRENCE OF SYSTEM FAULT 223 IN
THE DEVICE. IT WAS DETERMINED THAT THE CAUSE OF THE SYSTEM FAULT WAS A DEFECTIVE
WAS SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
HAD A BATTERY RETENTION ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED INVESTIGATION SITE LOCATED IN
(4).
EXTERNAL BATTERY HAD A CHARGING ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN (B)(4) AND IS CURRENTLY BEING RETURNED TO RESMED (B)(4) FOR AN
ENGINEERING INVESTIGATION. THE METHOD, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
HAD A BATTERY CHARGING ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
FAULT WAS DUE TO A DEFECTIVE POWER SUPPLY UNIT AND BATTERY COVER. THE PSU AND
BATTERY COVER WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED (B)(4) THAT THE ASTRAL
DEVICE TOUCHSCREEN HAD RANDOM DISPLAY FAILURES. THERE WAS NO PATIENT INJURY
REVEALED THAT THE UP AND DOWN ARROWS IN THE TOUCHSCREEN MENU IN AN ASTRAL DEVICE
ARE NOT ALWAYS RESPONDING. THE ASTRAL TOUCHSCREEN WAS RECALIBRATED WHICH RESOLVED
THE DISPLAY ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE
IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
FRA|Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED FRANCE THAT AN
RESMED REFERENCE #: (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED
PRELIMINARY EVALUATION IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO
REPORTABLE.
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES (SF 218 AND 148) AND THE
VENTILATION STOPPED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED SERVICE CENTER IN (B)(4) FOR
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL POWER
SUPPLY WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE POWER SUPPLY WAS RETURNED TO RESMED SERVICE CENTER IN (B)(4) AND
AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE POWER SUPPLY UNIT
(PSU) NOT FUNCTIONING; NO POWER. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
ASTRAL|Malfunction|Failure to Calibrate|IT WAS REPORTED TO THE RESMED SERVICE
CENTER IN (B)(4) THAT AN ASTRAL PNEUMATIC BLOCK FAILED TO PASS ITS INTERNAL SELF-
TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED BY THE
RESMED MANUFACTURING FACILITY IN (B)(4). THE INVESTIGATION DETERMINED THAT THE
VALVE (NRV) IN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK IS REPLACED TO ADDRESS THIS
TECHNICAL SERVICE CENTER IN FRANCE AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAILED COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A
IS ACCEPTABLE. (B)(4). NOTE: AT THE TIME THIS SELF-TEST COMPLAINT WAS REPORTED TO
THE MANUFACTURER, IT WAS ASSESSED AS BEING A NON-REPORTABLE EVENT. THE PRELIMINARY
EVALUATION IDENTIFIED NEW INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE.
DEVICE ALARMED, THE SCREEN TURNED BLACK AND BECAME INOPERABLE. THERE WAS NO PATIENT
SERVICE CENTER IN (B)(4) FOR INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
Malfunction|Charging Problem;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 180) MESSAGE. THE BATTERY
WAS NOT CHARGING. PER THE REPORTER, THE PATIENT WAS ADMITTED TO INPATIENT FACILITY
ALLEGEDLY DUE TO VENTILATOR ERRORS. NO SERIOUS PATIENT INJURY WAS REPORTED AS A
RESULT OF THIS INCIDENT. THE PATIENT HAD TWO VENTILATORS. THE WHEEL CHAIR
VENTILATOR, SERIAL NUMBER (B)(4), IS ADDRESSED IN THIS MEDWATCH REPORT. BACK-UP
VENTILATOR FOR NOCTURNAL USE, SERIAL NUMBER (B)(4), IS REPORTED IN RESMED MEDWATCH
REPORT 3004604967-2016-00691.|THE DEVICE WAS RETURNED TO THE RESMED SERVICE CENTER
IN (B)(4) FOR AN EVALUATION. A REVIEW OF THE DEVICE LOG FOUND TWO OCCURRENCES OF
SYSTEM FAULT 180 INDICATING A BATTERY CHARGER FAULT. DEVICE EVALUATION FOUND DAMAGE
AROUND THE POWER INLET PREVENTING THE PLUG IN THE POWER SUPPLY UNIT (PSU) FROM
BEING FULLY INSERTED. AS A RESULT, THE REPORTED BATTERY CHARGING ISSUE WAS DUE TO
THE PSU PLUG NOT CONNECTING WITH THE POWER INLET. RESMED'S RISK ANALYSIS FOR THIS
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 131) MESSAGE. PER THE REPORTER, THE
PATIENT WAS ADMITTED TO INPATIENT FACILITY ALLEGEDLY DUE TO VENTILATOR ERRORS. NO
SERIOUS PATIENT INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT. NOTE: THE PATIENT
HAD TWO VENTILATORS: THE WHEEL CHAIR VENTILATOR, SERIAL NUMBER (B)(4), IS REPORTED
IN RESMED MEDWATCH REPORT 3004604967-2016-00690. BACK-UP VENTILATOR FOR NOCTURNAL
USE, SERIAL NUMBER (B)(4), IS ADDRESSED IN THIS MEDWATCH REPORT.|THE DEVICE WAS
RETURNED TO THE RESMED SERVICE CENTER IN (B)(4) FOR AN EVALUATION. THE EVALUATION
CONFIRMED THE OCCURENCE OF SYSTEM FAULT (SF 131) AND COULD NOT BE REPRODUCED DURING
IN-HOUSE TESTING. THE RETURNED DEVICE PASSED ALL SERVICE TESTING. THE DEVICE WAS
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED (B)(4) THAT THE ASTRAL
DEVICE IS NOT CHARGING WHEN CONNECTED TO THE AC. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE MANUFACTURING
(4).
FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO
RESMED SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
RESMED SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED SERVICE
ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 191) MESSAGE. THE DEVICE WAS NOT IN USE
WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE
WAS RETURNED TO THE RESMED SERVICE CENTER IN (B)(4) FOR AN EVALUATION. THE
EVALUATION REVEALED THAT THE DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. A
REVIEW OF THE DEVICE LOG CONFIRMED A SINGLE OCCURRENCE OF SF 191 INDICATING A LOSS
OF COMMUNICATION WITH THE OUTLET FLOW SENSOR. THE PNEUMATIC BLOCK WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS
EXTERNAL BATTERY IS DEFECTIVE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE EXTERNAL BATTERY UNIT WAS RETURNED TO THE RESMED SERVICE CENTER
IN (B)(4) FOR AN EVALUATION. THE EVALUATION REVEALED THAT AN INTERNAL BATTERY
COMPONENT IN THE EXTERNAL BATTERY UNIT WAS NOT CHARGING. THE INTERNAL BATTERY WAS
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR.
RETURNED TO THE RESMED MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE
RESMED REFERENCE PR #: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 218) MESSAGE RESULTING IN AN
UNEXPECTED RESTART. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED SERVICE CENTER IN (B)(4). THE
EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)
(4).
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. RESMED WAS
UNABLE TO CONFIRM THE REPORTED SYSTEM FAULTS ON THE RETURNED DEVICE. DURING
EVALUATION, THE ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST FAILURE. IT
WAS DETERMINED THAT THE SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED,
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE CUSTOMER REPORTED TO RESMED THAT
A NEW PNEUMATIC BLOCK WAS INSTALLED IN THE ASTRAL DEVICE AND THIS ADDRESSED THE
INTERNAL SELF-TEST FAILURE. THE PNEUMATIC BLOCK WAS RETURNED TO RESMED FRANCE AND
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE PNEUMATIC BLOCK WAS
DEFECTIVE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. RESMED REFERENCE PR #: (B)(4). NOTE: DURING AN AUDIT OF THE COMPLAINT
RECORDS, IT WAS FOUND THAT THIS ISSUE SHOULDE BE REPORTED. THIS REPORT IS SUBMITTED
TO ADDRESS THE REPORTABLE EVENT.
SERVICE CENTER FOR EVALUATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION
ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE PR #: (B)(4).
Malfunction|Power Problem;Failure to Calibrate|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND THE POWER
SUPPLY WAS FAULTY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
AND AN EVALUATION WAS PERFORMED. THE DEVICE EVALUATION DID NOT CONFIRM THE INTERNAL
SELF-TEST FAILURE. THE EVALUATION ALSO FOUND THAT POWER SUPPLY WAS DEFECTIVE AND
WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED, CALIBRATED, AND TESTED
BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE
MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE PR #: (B)(4).
DEVICE WAS NOT ABLE TO START. THE DEVICE WAS NOT IN USE AND IN STANDBY MODE AT THE
TIME OF THE EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND AN ENGINEERING INVESTIGATION
WAS PERFORMED. THE ENGINEERING INVESTIGATION DETERMINED THAT THE DEVICE NOT ABLE TO
START WAS DUE TO THE POWER MANAGEMENT SOFTWARE CONFIGURATION WHEN THE DEVICE IS IN
THE STANDBY MODE AND NOT IN USE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE PR #: (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE ALARMED AND WOULD NOT PROCEED TO ITS NORMAL
START-UP SEQUENCE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE,
SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION BY RESMED
MANUFACTURING FACILITY LOCATED IN (B)(4) DETERMINED THAT THE ALARM SOUNDED
APPROPRIATELY AND THE BOOT-UP FAULT WAS LIKELY DUE TO AN ISOLATED SOFTWARE ERROR.
THE DEVICE WAS POWER CYCLED TO ADDRESS THIS SINGLE OCCURRENCE. RESMED'S RISK
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 75, SF 218) MESSAGES. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED
TO RESMED FOR EVALUATION. THE ASTRAL DEVICE WAS RETURNED TO A RESMED DISTRIBUTOR IN
(B)(4) AND A TECHNICAL EVALUATION WAS PERFORMED. THE DISTRIBUTOR'S TECHNICAL
EVALUATION FOUND SYSTEM FAULTS (SF75 AND SF218) IN THE ALARM LOG AND CONTACTED THE
RESMED SERVICE CENTER IN (B)(4) FOR ASSISTANCE ON HOW TO ADDRESS THIS ISSUE. A
RESMED SERVICE REPRESENTATIVE WENT THROUGH THE TROUBLESHOOTING STEPS WITH THE
DISTRIBUTOR AND RECOMMENDED TESTS TO VERIFY DEVICE PERFORMANCE. THE DISTRIBUTOR WAS
INFORMED TO CONTACT RESMED IF ADDITIONAL ASSISTANCE IS NEEDED. RESMED REFERENCE
PR#: (B)(4).
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS
EVALUATION WAS PERFORMED. THE EVALUATION FOUND THAT THE POWER CORD WAS DAMAGED AND
THE WIRES WERE EXPOSED. THE EVALUATION ALSO FOUND THAT THE BATTERY WAS NOT
CHARGING. THE MAIN PCB WAS REPLACED TO ADDRESS THE BATTERY CHARGING ISSUE. THE
DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
(B)(4).
REFERENCE PR #: (B)(4).
TECHNICAL SERVICE CENTER IN BREMEN, GERMANY AND AN EVALUATION WAS PERFORMED. THE
ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 65) MESSAGE. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(6) AND AN EVALUATION WAS PERFORMED. REVIEW OF THE
DEVICE LOG CONFIRMED THAT A SINGLE OCCURRENCE OF SYSTEM FAULT 65 WAS RECORDED.
HOWEVER, THE EVALUATION AND FUNCTIONAL TESTING COULD NOT REPRODUCE THE SYSTEM
FAULT. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE. (B)(4).
Malfunction|Power Problem;Device Displays Incorrect Message;Device Stops
Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A POWER
FAILURE AND AN ALARM WAS TRIGGERED THAT NOTIFIED THE CAREGIVER OF THE EVENT. THERE
RECEIVED BY RESMED (B)(4) AND IT WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. IMPORTANT RECORD
INFORMATION: IT WAS REPORTED TO RESMED THAT THE CUSTOMER INADVERTENTLY MIXED TWO
DEVICES REPORTS WHEN CONTACTING THE MANUFACTURER TO THE REPORT THE DEVICES
INCIDENTS. IT IS UNCLEAR WHICH UNIT HAD THE REPORTED ISSUE; THEREFORE, RESMED WILL
BE REPORTING BOTH DEVICES. REFERENCE RESMED MEDWATCH 3004604967-2016-00716. (B)(4).
Malfunction|Failure to Calibrate|IT WAS REPORTED TO RESMED GERMANY THAT AN ASTRAL
TECHNICAL SERVICE CENTER IN BREMEN, GERMANY AND AN EVALUATION WAS PERFORMED. THE
ACCEPTABLE. (B)(4).
Malfunction|Power Problem;Device Displays Incorrect Message;Device Stops
Intermittently|IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A POWER
FAILURE AND AN ALARM WAS TRIGGERED THAT NOTIFIED THE CAREGIVER OF THE EVENT. THERE
RECEIVED BY RESMED (B)(4) AND IT WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED
IN(B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. IMPORTANT RECORD
INFORMATION: IT WAS REPORTED TO RESMED THAT THE CUSTOMER INADVERTENTLY MIXED TWO
DEVICES REPORTS WHEN CONTACTING THE MANUFACTURER TO THE REPORT THE DEVICES
INCIDENTS. IT IS UNCLEAR WHICH UNIT HAD THE REPORTED ISSUE; THEREFORE, RESMED WILL
BE REPORTING BOTH DEVICES. REFERENCE RESMED MEDWATCH 3004604967-2016-00717. (B)(4).
RESMED (B)(4) THAT AN ASTRAL DEVICE POWERED OFF AT 30% CHARGE IN BATTERY RESULTING
IN A SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IT WAS RETURNED TO THE
AT THIS STAGE. RESMED REFERENCE PR #: (B)(4).
Malfunction|Defective Component|IT WAS REPORTED TO RESMED (B)(4) THAT AN NRV TUBE
CONNECTOR WAS BROKEN IN AN ASTRAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE
NON-RETURN VALVE (NRV) TUBE CONNECTOR IN THE PNEUMATIC BLOCK WAS BROKEN. THIS ISSUE
WILL RESULT IN THE DEVICE TO FAIL ITS INTERNAL SELF-TEST. THE PNEUMATIC BLOCK WAS
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE PR #: (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 65 MESSAGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS BEEN IN COMMUNICATION WITH THE
CUSTOMER TO GATHER ADDITIONAL INFORMATION ABOUT THE DEVICE AND THE REPORTED ISSUE.
RESMED HAS ALSO REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING
PR #: (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 180 MESSAGE. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE
DEVICE LOG REVEALED A SINGLE OCCURRENCE OF SYSTEM FAULT 180 INDICATING A BATTERY
CHARGER FAULT. PERFORMANCE TESTING WAS NOT ABLE TO REPRODUCE THE FAULT. THE
EVALUATION DETERMINED THAT THE SYSTEM FAULT WAS DUE TO A DEFECTIVE BATTERY. THE
BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED,
CENTER IN MORENO VALLEY, CA AND AN EVALUATION WAS PERFORMED. THE EVALUATION
(B)(4).
AN ASTRAL DEVICE ALARMED INDICATING TO THE CAREGIVER OF AN ISSUE, THEN PROCEEDED TO
AUTOMATICALLY SWITCH-OFF. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED MANUFACTURING FACILITY LOCATED IN
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE
DEVICE LOG REVEALED THE OCCURRENCE OF SYSTEM FAULT 147 INDICATING A MAIN BLOWER
ISSUE. THE DEVICE EVALUATION FOUND THE ROOT CAUSE TO BE THE BLOWER ASSEMBLY. THE
BLOWER ASSEMBLY WAS SERVICED TO RESOLVE THE ISSUE. THE DEVICE WAS CALIBRATED AND
Malfunction|Device Displays Incorrect Message|IT WAS REPORTED BY RESMED THAT AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 147) MESSAGE DURING SERVICING. THERE WAS
EVALUATION DETERMINED THAT THE SYSTEM FAULT (SF 147) WAS DUE TO WATER DAMAGE IN THE
AN ASTRAL DEVICE ALARMED RESULTING IN AN UNEXPECTED RESTART. THERE WAS NO PATIENT
CENTER LOCATED IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
ACCEPTABLE. (B)(4).
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 180) INDICATING A BATTERY CHARGER
FAULT OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE RESMED FACILITY IN (B)(4) AND AN INVESTIGATION WAS
PERFORMED. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE FOR THE SYSTEM FAULT
WAS THE INTERNAL BATTERY PACK. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
REFERENCE: (B)(4).
TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. REVIEW OF THE
DEVICE LOGS CONFIRMED A SINGLE OCCURRENCE OF SYSTEM FAULT 223 INDICATING A PEEP
BLOWER FAILURE. THE EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THE SYSTEM
FAULT WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT MESSAGES RESULTING IN A SAFETY RESET. THERE
RETURNED TO THE RESMED MANUFACTURING FACILITY LOCATED IN (B)(4) FOR AN EXTENSIVE
DISPLAYED AN ERROR MESSAGE, "INTERNAL BATTERY INOPERABLE." THIS RESULTED IN AN
ALARM TO NOTIFY THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY
DETERMINED THAT THE "INTERNAL BATTERY INOPERABLE" ALARM WAS DUE TO THE ASTRAL
BATTERY PACK (B)(4). THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE AND DEVICE WAS
RETURNED TO THE CUSTOMER. THE ASTRAL BATTERY PACK IS BEING RETURNED TO (B)(6) FOR
Malfunction|Appropriate Term/Code Not Available|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE HAD A MOTOR ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED (B)(4) FOR AN EXTENSIVE
CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THE FAILURE TO
PASS THE SELF TEST WAS DUE TO A SOFTWARE PROBLEM. THE DEVICE WAS CLEANED, SERVICED,
(B)(4).
ASTRAL DEVICE WAS BEING CONFIGURED FOR THE PATIENT IT FAILED TO COMPLETE ITS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-
TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE
IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
5806737|20160619|NOU|Continuous, Ventilator, Home Use|27918|ASTRAL BATTERY|
BATTERY INADVERTENTLY LOST CONNECTION. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED (B)(4) TECHNICAL
SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
(B)(4).
Malfunction|Device Alarm System;No Display / Image|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE ALARMED AND THE SCREEN WAS BLACK. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER IN (B)(4) FOR INVESTIGATION. BASED ON ALL AVAILABLE
EVIDENCE, THE MOST LIKELY CAUSE FOR THE SCREEN GOING BLACK WAS THE OPERATOR AND
CAREGIVER ALLOWING THE BATTERY TO DEPLETE. THE INVESTIGATION ALSO FOUND THE DEVICE
DISPLAY BUTTON DAMAGED FROM PHYSICAL ABUSE. RESMED REFERENCE PR #: (B)(4).
(B)(4).
ACCEPTABLE. (B)(4).
Malfunction|Battery Problem|IT WAS REPORTED BY THE RESMED TECHNICAL SERVICE THAT
THE ASTRAL BATTERY NEEDED TO BE REPLACED. THE DEVICE WAS NOT IN USE WHEN THE FAULT
THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR GENERAL SERVICE AND EVALUATION.
THERE WAS NO REPORTED DEVICE MALFUNCTION. DURING AN EXTENSIVE REVIEW OF THE DEVICE
LOGS FOUND THAT THE BATTERY NEEDED TO BE REPLACED. THE BATTERY IN THE DEVICE WAS
REPLACED DURING SERVICE. THE DEVICE WAS CALIBRATED AND TESTED BEFORE IT WAS
RETURNED TO THE CUSTOMER. RESMED'S RISK ANAYLSIS FOR THIS FAILURE MODE CONCLUDES
Malfunction|Battery Problem|IT WAS REPORTED BY THE RESMED TECHNICAL SERVICE THAT
THE ASTRAL BATTERY NEEDED TO BE REPLACED. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE
CENTER IN (B)(4) A FOR EVALUATION AND REPAIR. THE EVALUATION DETERMINED THAT THE
DEVICE ISSUE WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO ADDRESS
THIS ISSUE. (B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO A RESMED
(4).
(B)(4).
AN ASTRAL DEVICE HAD A POWER FAILURE AND AN ALARM WAS TRIGGERED THAT NOTIFIED THE
CAREGIVER OF THE EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED MANUFACTURING
(4).
ACCEPTABLE. RESMED REFERENCE PR #: (B)(4).
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED (B)(4) THAT THE LCD SCREEN
IN AN ASTRAL DEVICE WAS NOT RESPONDING TO TOUCH. THERE WAS NO PATIENT INJURY
AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE LCD TOUCH SCREEN WAS
NOT RESPONDING. THE LCD MODULE WAS RECALIBRATED TO ADDRESS THIS ISSUE. THE DEVICE
WAS SERVICED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
(B)(4).
(B)(4).
Malfunction|Failure to Calibrate;No Display / Image|IT WAS REPORTED BY RESMED THAT
AN ASTRAL DEVICE HAD AN CRACKED DISPLAY SCREEN AND FAILED TO PASS ITS INTERNAL SELF
WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY ISSUE WAS CAUSED BY PHYSICAL
DAMAGE (IMPACT) TO THE SCREEN. THE TOUCHSCREEN WAS REPLACED TO ADDRESS THIS ISSUE.
THE EVALUATION ALSO DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL
SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED
THE RISK IS ACCEPTABLE RESMED REFERENCE #: (B)(4).
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. NOTE: AT
CHANGE THE ASSESSMENT TO REPORTABLE. RESMED REFERENCE PR #: (B)(4).
(B)(4).
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE.
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE PR #: (B)(4).
WAS DISPLAYING A DC INDICATOR EVEN THOUGH THE POWER SUPPLIED WAS AC. THERE WAS NO
THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAILURE TO RECOGNIZE THE CORRECT POWER SOURCE WAS DUE TO
A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED TECHNICAL
INFORMATION TO CHANGE THE ASSESSMENT TO REPORTABLE. RESMED REFERENCE PR #: (B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND
Malfunction|Power Problem|IT WAS REPORTED TO RESMED (B)(4) THE ASTRAL POWER SUPPLY
UNIT (PSU) WAS FAULTY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND AN EVALUATION WAS PERFORMED.
THE EVALUATION OBSERVED THAT THE GREEN LIGHT INDICATOR IN THE PSU WAS NOT ON. IT
WAS DETERMINED THAT THE PSU WAS FAULTY. THE POWER SUPPLY WAS REPLACED, THE DEVICE
WAS SERVICED AND RETURNED TO THE CUSTOMER. (B)(4).
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. NOTE: AT THE TIME THIS SELF-
ASSESSMENT TO REPORTABLE. (B)(4).
TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE WAS
SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
(B)(4).
(B)(4).
(B)(4).
Malfunction|Power Problem;Device Stops Intermittently|IT WAS REPORTED TO RESMED (B)
(4) THAT AN ASTRAL DEVICE HAD AN UNEXPECTED POWER FAILURE WHILE VENTILATING A
PATIENT. THE PATIENT WAS MANUALLY VENTILATED WHILE THE BACKUP VENTILATION WAS SET
UP. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
WAS RETURNED TO RESMED (B)(4) AND A PRELIMINARY INVESTIGATION WAS PERFORMED. THE
REPORTED ISSUE THAT THE DEVICE STOPPED VENTILATING WAS CONFIRMED. A REVIEW OF THE
DEVICE HISTORY LOGS INDICATES THAT A LOW BATTERY ALARM DID NOT TRIGGER, HOWEVER,
WHEN THE VENTILATION STOPPED THE CONTINUOUS AUDIBLE ALARM TRIGGERED AS PER DESIGN.
THE DEVICE IS UNDER INVESTIGATION BY RESMED PARIS AND THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR
SCREEN WAS FROZEN AND UNRESPONSIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
TO RESMED FOR EVALUATION. A RESMED PRODUCT SUPPORT SPECIALIST WENT THROUGH THE
TROUBLESHOOTING STEPS AND ADVISED THE CUSTOMER OF POSSIBLE CAUSES. THE CUSTOMER WAS
ADVISED TO PERFORM A HARD REBOOT AND THIS RESOLVED THE DISPLAY SCREEN ISSUE. (B)
(4).
RESMED THAT A SYSTEM FAULT (SF 180) OCCURRED ON AN ASTRAL DEVICE INDICATING A
BATTERY CHARGER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED SERVICE CENTER IN (B)(4) FOR AN
EVALUATION. A REVIEW OF THE DEVICE LOG FOUND A SYSTEM FAULT 180 OCCURENCE
INDICATING A BATTERY CHARGER FAULT. THE DEVICE IS CURRENTLY UNDER INVESTIGATION AT
THE DESIGN HOUSE IN (B)(4). INVESTIGATION METHODS, RESULTS AND CONCLUSIONS ARE NOT
FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6)
(B)(4).
DEVICE WAS RECEIVED BY THE (B)(6) SERVICE CENTER IN (B)(6) AND AN EVALUATION WAS
FOUND WITH THE RETURNED DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 75) AND "SAFETY RESET" (SF 218) ERROR
MESSGES. THERE WAS NO PATIENT INJURY INVOLVEMENT.|THE DEVICE WAS RECEIVED BY THE
RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE SF 75 AND SF 218 OCCURED AS A RESULT OF A ROUTINE
SERVICE OF THE DEVICE AND UNDER THE CONTROL OF THE SERVICE CENTER. RESMED'S RISK
(B)(4).
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE (B)(6) SERVICE CENTER IN
WOULD NOT CHARGE ITS BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING INVESTIGATED BY RESMED IN (B)(6) AND
REPORTED TO RESMED (B)(4) THAT WHILE A NURSE WAS ADDING A NEBULIZER TO A VENTILATOR
THE ASTRAL DEVICE STOPPED VENTILATION AND ALARMED FOR LOW VTI. THE NURSE
DISCONNECTED THE ASTRAL AND NEBULIZER AND BEGAN TO VENTILATE THE PATIENT MANUALLY.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE IS
CURRENTLY BEING INVESTIGATED BY RESMED IN (B)(4) AND THE INVESTIGATION METHODS,
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANAYLSIS FOR
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED AN ALARM. THERE WAS
ACCEPTABLE. (B)(4).
DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED A WARNING ALARM.
PERFORMED. THE ALARM WAS REPRODUCED DURING THE EVALUATION. THE EVALUATION
(B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL VENTILATOR'S
POWER SUPPLY UNIT (PSU) WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO
TIME. A REPLACEMENT POWER SUPPLY UNIT HAS BEEN SENT TO THE CUSTOMER. RESMED
TECHNICAL SERVICE CENTER IN ENGLAND AND AN EVALUATION WAS PERFORMED. THE EVALUATION
THE DEVICE WAS SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE
TECHNICAL SERVICE CENTER ENGLAND AND AN EVALUATION WAS PERFORMED. THE EVALUATION
TECHNICAL SERVICE CENTER IN FRANCE AND AN EVALUATION WAS PERFORMED. THE EVALUATION
(B)(4).
CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
AN ASTRAL DEVICE DISPLAYED SF 218 AND SF 101 ERROR MESSAGES. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE FAULTS WERE DUE TO A DEFECTIVE MOTOR. THE MOTOR WAS
FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED AN ALARM. THERE WAS NO
THE (B)(6)SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED
PNEUMATIC BLOCK AND EXPIRATORY FLOW SENSOR. THE PNEUMATIC BLOCK WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE
VENTILATOR'S POWER SUPPLY UNIT (PSU) WAS NOT FUNCTIONING. THERE WAS NO PATIENT
DETERMINED THAT THE DEVICE'S DEFECTIVE POWER SUPPLY UNIT (PSU) WAS DUE TO A
DEFECTIVE POWER CORD CAUSED BY PHYSICAL ABUSE. THE MAIN CIRCUIT BOARD (PCB) AND
POWER SUPPLY UNIT WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
DETERMINED THAT THE SYSTEM FAULT 131 COULD BE REPRODUCED DURING IN-HOUSE TESTING.
THE PNEUMATIC BLOCK WAS REPLACED AS TO ADDRESS THIS ISSUE. THE DEVICE WAS RETURNED
TO THE DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION.
(B)(4).
Malfunction|Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED FRANCE THAT
AN ASTRAL VENTILATOR'S BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED IN (B)(4)
FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION
EUR4|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED (B)(4)
THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 101) AND SYSTEM FAULT (SF 218)
INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO
EVALUATION DETERMINED THAT THE SYSTEM FAULT 101 WAS DUE TO WATER CONTAMINATION
WITHIN THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Malfunction|Failure to Charge;Device Stops Intermittently|IT WAS REPORTED TO RESMED
(B)(4) THAT AN ASTRAL DEVICE HAD A BATTERY CHARGING ISSUE. IT WAS ALSO REPORTED
THAT THE DEVICE POWERED DOWN WITH A LOW BATTERY ALARM. THERE WAS NO PATIENT INJURY
INVESTIGATION TEAM IN (B)(6) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. RESMED REFERENCE#: (B)(4).
BATTERY, ROW|Malfunction|Battery Problem;Failure to Discharge|IT WAS REPORTED TO
RESMED THAT AN ASTRAL BATTERY FAILED TO DISCHARGE AS INTENDED. THERE WAS NO PATIENT
HARM OR INJURY REPORTED FOR THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED
THAT THE DEVICE BATTERY FAILURE TO DISCHARGE AS INTENDED WAS DUE TO A FAULTY
BATTERY. THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY
Malfunction|Failure to Power Up;Power Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|RESMED HAS REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING
Malfunction|Failure to Charge;Battery Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE BATTERY WILL NOT CHARGE. THE DEVICE WAS NOT USED ON A PATIENT WHEN
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE CHARGING ISSUE WAS DUE TO A FAULTY BATTERY. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED,
ANALYSIS FOR THIS ISSUE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 75) AND SYSTEM FAULT (SF 195) ERROR
MESSAGES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
PERFORMED. THE EVALUATION DETERMINED THAT THE DISPLAY FAULTS OCCURRED AS A RESULT
OF A ROUTINE DEVICE SERVICE AND UNDER THE CONTROL OF THE SERVICE CENTER. THE MAIN
PCB AND PNEUMATIC BLOCK WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANAYLSIS
BATTERY, ROW|Malfunction|Battery Problem;Failure to Discharge|IT WAS REPORTED TO
RESMED THAT AN ASTRAL BATTERY FAILED TO DISCHARGE AS INTENDED. THERE WAS NO PATIENT
HARM OR INJURY REPORTED FOR THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED
THAT THE DEVICE BATTERY FAILURE TO DISCHARGE AS INTENDED WAS DUE TO A FAULTY
BATTERY. THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK
FAILED TO COMPLETE ITS INTERNAL SELF-TEST.. THERE WAS NO PATIENT INJURY REPORTED AS
(4).
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED,
ASTRAL DEVICE DISPLAYED A CONTINUOUS WARNING ALARM OF LOW POSITIVE EXPIRATORY END
PRESSURE AT THE DISTRIBUTOR SITE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED
INVESTIGATION SITE FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR
OCCURRED. THIS RESULTED IN AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO
THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION
THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4).
Malfunction|Battery Problem;Failure to Charge|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" MESSAGE. THERE WAS NO PATIENT INJURY
TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE REPORTED "BATTERY
INOPERABLE" MESSAGE WAS CONFIRMED THROUGH REVIEW OF THE DEVICE LOGS. THE EVALUATION
DETERMINED THAT THE DEVICE CHARGING FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY.
THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
Malfunction|Failure to Charge;Battery Problem|IT WAS REPORTED BY RESMED THAT AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 180) INDICATING A BATTERY CHARGER FAULT
DEVICE IS UNDER INVESTIGATION BY RESMED PARIS AND THE INVESTIGATION METHODS,
SYSTEM FAULT (SF101) WAS OBSERVED ON AN ASTRAL DEVICE. THE SYSTEM FAULT OCCURRED
AFTER THE CAREGIVER INTENTIONALLY DEMONSTRATED A DISCONNECTION OF THE CIRCUIT WHILE
VENTILATING A PATIENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN
TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE
DISPLAYED A "BATTERY INOPERABLE" MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER AND AN EVALUATION WAS PERFORMED. THE REPORTED "BATTERY INOPERABLE" MESSAGE
WAS CONFIRMED THROUGH REVIEW OF THE DEVICE LOGS. THE EVALUATION COULD NOT REPRODUCE
THE BATTERY ISSUE DURING IN-HOUSE TESTING. THE EVALUATION REVEALED A BLOWER FAILURE
THAT WAS RESOLVED BY REPLACING THE PNEUMATIC BLOCK. THE DEVICE WAS SERVICED AND
(4).
5846952|20160708|NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 - DEU|No
answer provided|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
Malfunction|Device Alarm System|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
ALARMED AND THE VENTILATION STOPPED. THERE WAS NO PATIENT INJURY REPORTED AS A
CENTER AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS SHOWED HIGH
PRESSURE ALARMS WERE TRIGGERED PRIOR TO VENTILATION STOP. IN-HOUSE TESTING SHOWED
THAT THE DEVICE PERFORMED TO SPECIFICATION; RESULT IS "NO FAULT FOUND." THE DEVICE
ASTRAL DEVICE DISPLAYED THE MESSAGE "SWITCH OFF" AND THE FUNCTION "CONFIRM/CANCEL"
WAS MISSING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS SENT TO THE RESMED TECHNICAL SERVICE CENTER FOR AN ENGINEERING
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 74) INDICATING A SOFTWARE TASK
ERROR OCCURRED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RECEIVED BY THE (B)(6) SERVICE CENTER AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAULT WAS DUE A DEFECTIVE MAIN
CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT THE ASTRAL POWER SUPPLY
UNIT (PSU) WAS FAULTY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION. THE
DEVICE HAS NOT YET RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED
Malfunction|Device Stops Intermittently;Device Alarm System|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE HAD AN UNEXPECTED POWER FAILURE WHILE VENTILATING A
PATIENT. THE PATIENT WAS MANUALLY VENTILATED AND PLACED ON A BACK-UP VENTILATOR
WITH NO COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
STAGE. RESMED REFERENCE #:(B)(4).
EUR4|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT
OCCURRED RESULTING IN AN ALARM BEING TRIGGERED. THERE WAS NO PATIENT INJURY
SERVICE CENTER FOR AN EVALUATION. THE EVALUATION CONFIRMED THE OCCURENCE OF SYSTEM
FAULT (SF 74). IT IS POSSIBLE THAT THE FAULT WAS CAUSED BY A SOFTWARE TIMING ISSUE.
(B)(4).
RECOGNIZE ITS EXTERNAL POWER SUPPLY UNIT (PSU). THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS SENT TO THE RESMED TECHNICAL
SERVICE CENTER FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
FRA|Malfunction|Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR.
RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS PERFORMED.
THE REPORTED COMPLAINT WAS CONFIRMED THROUGH THE REVIEW OF THE DEVICE DATA LOGS.
THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 74 WAS DUE TO A SOFTWARE ISSUE. THE
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO A RESMED TECHNICAL SERVICE
Malfunction|Device Inoperable;No Display / Image|IT WAS REPORTED TO RESMED THAT
WHILE THE ASTRAL DEVICE WAS BEING CONFIGURED FOR THE PATIENT, IT ALARMED AND THE
SCREEN WAS BLACK. THERE WAS NO PATIENT CONNECTED AT THE TIME OF THE EVENT.|THE
DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION WAS
PERFORMED. THE DEVICE IS CURRENTLY BEING RETURNED TO (B)(4) FOR AN ENGINEERING
5877302|20160713|NOU|Continuous, Ventilator, Home Use|HT70|HT70 VENTILATOR|
Malfunction|No Display / Image|IT WAS REPORTED THAT A VENTILATOR DISPLAY FROZE AT
THE SIX PICTURE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.|COVIDIEN REFERENCE
NUMBER: (B)(4). MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE. THE
REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-MEDTRONIC SERVICE PROVIDER
REBOOTED THE DEVICE WITH THE SAME RESULT.
INDICATING A SOFTWARE TASK ERROR AND A TOTAL POWER FAILURE OCCURRED. THERE WAS NO
RESMED FOR EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT
Malfunction|Power Problem;Failure to Charge|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE WOULD NOT CHARGE ITS BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR EVALUATION. THE
EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE ALARM WAS TRIGGERED. THE ALARM
RESULTED IN AN UNEXPECTED RESTART OF THE DEVICE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR
THIS STAGE. (B)(4).
DEVICE STOPPED VENTILATION AFTER THE DEVICE SETTINGS WERE CHANGED AND AN ALARM WAS
TRIGGERED THAT NOTIFIED THE CAREGIVER OF THE EVENT. THE PATIENT WAS MANUALLY
VENTILATED WITH NO COMPLICATIONS WHILE THE DEVICE WENT THROUGH ITS STARTUP
SEQUENCE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED FOR EVALUATION. THE PRILIMINARY EVALUATION COULD NOT
REPRODUCE THE VENTILATION STOP DURING TESTING. THE EVALUATION METHODS, RESULTS, AND
ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF101 AND 218). THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED TECHNICAL
SERVICE CENTER IN (B)(4) FOR EVALUATION. THE INVESTIGATION METHODS, RESULTS AND
CONCLUSION ARE NOT YET FINALIZED AT THIS STAGE. (B)(4).
REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS IN STANDBY MODE AND NOT IN USE,
IT DISPLAYED A SYSTEM FAULT MESSAGE (SF 74) INDICATING A SOFTWARE TASK ERROR
OCCURRED AND THE VENTILATION STOPPED. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. THE
(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 188) ERROR MESSAGE. THE DEVICE WAS NOT
IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE
DEVICE WAS RECEIVED BY THE (B)(6) SERVICE CENTER AND AN EVALUATION WAS PERFORMED.
REVIEW OF THE DEVICE LOG CONFIRMED THAT THE OCCURRENCE OF SYSTEM FAULT 188. THE
DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING FACILITY FOR AN ENGINEERING
Malfunction|Power Problem;Device Stops Intermittently|IT WAS REPORTED TO RESMED
THAT AN ASTRAL DEVICE HAD A POWER FAILURE. THERE WAS NO INDICATION THAT THE FAILURE
OCCURED DURING VENTILATION OR THAT ALARMS DID NOT FUNCTION AS DESIRED. THERE WAS NO
RESMED FOR INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE
REPORTED TO RESMED THAT SYSTEM FAULT (SF101 AND SF218) MESSAGES WERE OBSERVED ON AN
ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT.
THIS RESULTED IN VENTILATION STOPPING AND AN ALARM NOTIFYING THE CAREGIVER OF THE
EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
PERFORMED. THE REPORTED SYSTEM FAULTS 101 AND 218 WERE CONFIRMED THROUGH REVIEW OF
THE DEVICE DATA LOGS. THE EVALUATION DETERMINED THAT THE DEVICE FAULTS WERE DUE TO
WATER CONTAMINATION WITHIN THE PNEUMATIC BLOCK AND INLET SEAL. THE PNEUMATIC BLOCK
AND INLET ASSEMBLY WERE REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
(4).
5887735|20160725|NOU|Continuous, Ventilator, Home Use|27093|ATRAL 150 - FUKUDA|
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 218) MESSAGE. THIS RESULTED IN AN ALARM
WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN
EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOG CONFIRMED THAT THE OCCURRENCE OF
SYSTEM FAULT 218. THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURING
FACILITY FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND
CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR THE
PATIENT, IT DISPLAYED SYSTEM FAULT (SF 218 AND SF 188) ERROR MESSAGES AND THE
VENTILATION STOPPED. THIS RESULTED IN AN ALARM NOTIFYING THE USER OF THE ERROR
MESSAGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED AND AN EVALUATION WAS PERFORMED.
THE PRELIMINARY EVALUATION OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED
VENTILATION STOP AND SYSTEM FAULT (SF 218 AND SF 188) ERROR MESSAGES. THE DEVICE IS
CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE ENGINEERING
Malfunction|Charging Problem;Power Problem|IT WAS REPORTED BY RESMED THAT DURING A
SERVICE CENTER EVALUATION OF AN ASTRAL DEVICE, THE INTERNAL BATTERY FAILED TO
PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING ISSUE WAS DUE TO A FAULTY
BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK
Malfunction|Charging Problem;Power Problem|IT WAS REPORTED BY RESMED THAT DURING A
SERVICE CENTER EVALUATION OF AN ASTRAL DEVICE, THE INTERNAL BATTERY FAILED TO
PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING ISSUE WAS DUE TO A FAULTY
BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK
Malfunction|Power Problem;Charging Problem|IT WAS REPORTED BY RESMED THAT AN ASTRAL
DEVICE FAILED TO CHARGE AND DISPLAYED THE ERROR MESSAGE "BATTERY INOPERABLE" WHICH
RESULTED IN AN ALARM NOTIFYING THE USER OF THE EVENT. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE CHARGING ISSUE AND
ERROR MESSAGE WERE DUE TO A FAULTY BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
ASTRAL DEVICE DISPLAY SCREEN WAS INOPERABLE. THERE WAS NO PATIENT HARM OR INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED FOR
EVALUATION. THE EVALUATION CONFIRMED THE TOUCHSCREEN DISPLAY WAS INOPERABLE DUE TO
PHYSICAL DAMAGE OF THE SCREEN. THE DISPLAY WAS REPLACED TO ADDRESS THIS ISSUE.
RESMED REFERENCE#: (B)(4).
Malfunction|Power Problem;Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE'S INTERNAL BATTERY WAS NOT CHARGING AND THE DEVICE DETECTED THE INCORRECT
POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED POWER ISSUES WERE DUE TO
A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
CONCLUDES THAT THE RISK IS ACCEPTABLE. . RESMED REFERENCE #: (B)(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A POWER FAILURE AND DISPLAYED AN
ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE PRELIMINARY
EVALUATION OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED TOTAL POWER FAILURE AND
ALARM MESSAGE. THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A
CHARGING ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED TECHNICAL SERVICE CENTER FOR
FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED ERROR MESSAGES ( SF75, 218
AND 219). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST AND ERROR
MESSAGES WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD AN
UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE DISPLAY FAILURE WAS DUE TO A FAULTY TOUCH SCREEN.
THE TOUCH SCREEN WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4) .
Malfunction|Failure to Charge;Battery Problem;Charging Problem|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY INOPERABLE" ALARM AND WOULD NOT
HOLD CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DETERMINED THAT THE BATTERY INOPERABLE ALARM AND CHARGING FAULT WAS DUE TO A
DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
ACCEPTABLE. (B)(4).
5904214|20160726|NOU|Continuous, Ventilator, Home Use|19803|FUKUDA TOP CASE -
ASTRAL|Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT DURING
SERVICING, AN ASTRAL DEVICE HAD AN INOPERABLE TOUCHSCREEN. THE DEVICE WAS NOT IN
DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE FOR AN EXTENSIVE
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 189) ERROR MESSAGE INDICATING A LOSS OF
COMMUNICATION. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR
DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) ERROR MESSAGE INDICATING A SOFTWARE
TASK ERROR OCCURRED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN
EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE OCCURENCE OF SYSTEM FAULT
(SF 74). THE EVALUATION DETERMINED THAT THE SYSTEM FAULT WAS A SINGLE OCCURRENCE
AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE WAS SERVICED AND
Malfunction|Battery Problem;Failure to Charge;Charging Problem|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE'S INTERNAL BATTERY FAILED TO CHARGE PROPERLY. THERE
RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT
THE DEVICE BATTERY AND CHARGING FAULT WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. REVIEW OF THE DEVICE
LOGS CONFIRMED THE SELF-TEST FAILURE AND REVEALED A SINGLE OCCURENCE OF A SYSTEM
FAULT 74 INDICATING A SOFTWARE TASK OCCURED. THE PNEUMATIC BLOCK WAS REPLACED TO
Malfunction|Charging Problem;Power Problem;Device Displays Incorrect Message|IT WAS
REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR USE, ITS
BATTERY WOULD NOT CHARGE AND DISPLAYED A SYSTEM FAULT (SF 180) MESSAGE INDICATING A
BATTERY CHARGER FAULT. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE REPORTED SYSTEM FAULT 180 COULD
NOT BE CONFIRMED THROUGH REVIEW OF THE DEVICE DATA LOGS. THE EVALUATION DETERMINED
THAT THE DEVICE FAILURE TO CHARGE ITS BATTERY WAS DUE TO A DEFECTIVE INTERNAL
RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING CONFIGURED FOR USE, IT DISPLAYED A
"BATTERY INOPERABLE" ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED;
THAT THE DEVICE FAULT WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED TO
Malfunction|Power Problem;Device Stops Intermittently|IT WAS REPORTED TO RESMED
THAT WHILE AN ASTRAL DEVICE WAS IN STANDBY MODE AND NOT ON A PATIENT, IT HAD A
POWER FAILURE AND DISPLAYED AN ALARM. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS
PERFORMED. THE PRELIMINARY EVALUATION OF THE DEVICE DATA LOGS CONFIRMED THE
REPORTED TOTAL POWER FAILURE AND ALARM MESSAGE. THE INVESTIGATION METHODS, RESULTS,
Malfunction|Circuit Failure|WHILE AN ASTRAL DEVICE WAS BEING EVALUATED FOR A
ROUTINE SERVICE, IT FAILED TO PASS ITS INTERNAL TESTS. THE DEVICE WAS NOT IN USE AT
THE TIME THE ISSUE WAS DETECTED.|THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL
SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
DEVICE FAILURE WAS DUE TO A DEFECTIVE MAIN PCB. THE MAIN PCB WAS REPLACED TO
ADDRESS THE ISSUE. THE MAIN PCB IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN
DEVICE WAS RETURNED TO RESMED FOR AN EVALUATION. THE EVALUATION CONFIRMED THE
OCCURENCE OF SYSTEM FAULT (SF 74). IT IS POSSIBLE THAT THE FAULT WAS CAUSED BY A
SOFTWARE TIMING ISSUE. THE EVALUATION ALSO FOUND WATER INGRESS IN THE PNEUMATIC
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED AND THE DEVICE WAS SERVICED, CALIBRATED,
AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 74) INDICATING A SOFTWARE TASK ERROR.
THIS CAUSED THE ASTRAL DEVICE TO PERFORM A SAFETY RESET. THE PATIENT WAS NOT BEING
VENTILATED AT THE TIME OF THE SYSTEM FAULT. THERE WAS NO PATIENT INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED AND AN EVALUATION
WAS PERFORMED. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH THE REVIEW OF THE
DEVICE DATA LOGS. THE EVALUATION DETERMINED THAT THE SINGLE OCCURRENCE OF THE
SYSTEM FAULT 74 WAS DUE TO A SOFTWARE ISSUE. THE DEVICE WAS SERVICED AND RETURNED
Malfunction|Failure to Calibrate;No Display / Image|IT WAS REPORTED BY RESMED THAT
WHILE AN ASTRAL DEVICE WAS BEING SERVICED, IT HAD AN INOPERABLE TOUCHSCREEN AND
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
TOUCHSCREEN WAS INOPERABLE DUE TO WATER INGRESS IN THE SCREEN. IT WAS ALSO
DEFECTIVE PNEUMATIC BLOCK. THE TOP CASE AND PNEUMATIC BLOCK WERE REPLACED TO
ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE IN SYDNEY, AUSTRALIA FOR
AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE
NOT YET FINALIZED AT THIS STAGE. (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF65) INDICATING A DATA ISSUE UPON
DEVICE START UP. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 65 WAS A SINGLE OCCURRENCE AND
COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. DEVICE HAS BEEN SENT TO THE DESIGN
HOUSE IN (B)(4) FOR AN ENGINEERING INVESTIGATION. (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 65) INDICATING A DATA ISSUE. THERE WAS
THE RESMED AND AN EVALUATION WAS PERFORMED. THE REPORTED COMPLAINT WAS CONFIRMED
THROUGH THE REVIEW OF THE DEVICE DATA LOGS. THE EVALUATION DETERMINED THAT THE
SYSTEM FAULT 65 WAS DUE TO A SOFTWARE ISSUE. THE DEVICE WAS SERVICED AND RETURNED
ASTRAL DEVICE DISPLAYED ERROR MESSAGE SF101 AND PERFORMED A SAFETY RESET WHILE THE
CAREGIVER WAS CHANGING THE PATIENT SETTINGS. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE DESIGN HOUSE IN (B)(4)
FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND CONCLUSION
ARE NOT YET FINALIZED AT THIS STAGE. (B)(4).
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT 74 AFTER A POWER
FAILURE EVENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO THE DESIGN HOUSE IN (B)(4) FOR AN ENGINEERING
INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE SF74 WAS DUE TO A SOFTWARE
ISSUE. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF65) INDICATING A DATA ISSUE UPON
DEVICE START UP. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR
AN EXTENSIVE ENGINEERING INVESTIGATION. THE METHODS, RESULTS, AND CONCLUSION ARE
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. THE
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF218). THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED FOR AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF74) INDICATING A SOFTWARE TASK ERROR.
RETURNED TO THE RESMED AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DOWNLOADED
DEVICE EVENTS LOG CONFIRMED THE OCCURRENCE OF SYSTEM FAULT 74 WAS TRIGGERED IN THE
DEVICE. THE SYSTEM TESTING PERFORMED BY TECHNICAL SERVICES COULD NOT REPRODUCE THE
FAULT. THE ROOT CAUSE FOR THE SF74 WAS AN ISOLATED SOFTWARE ISSUE. THE DEVICE WAS
SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
Malfunction|Power Problem|IT WAS REPORTED BY RESMED THAT WHILE AN ASTRAL DEVICE WAS
BEING SERVICED, IT DID NOT RECOGNIZE THE AC POWER WHEN PLUGGED INTO THE POWER
OUTLET. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER
AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE POWER ISSUE WAS
DUE TO A DAMAGED AC INLET SOCKET. THE CHASSIS WAS REPLACED TO ADDRESS THIS ISSUE.
THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
WILL NOT START. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE DEVICE FAILURE TO START WAS A SINGLE OCCURRENCE AND COULD NOT
BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE PERFORMED TO SPECIFICATIONS.
DEVICE HAD A POWER FAULT WHILE VENTILATING A PATIENT. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THE DEVICE PERFORMED TO
SPECIFICATIONS. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS
RESMED THAT WHILE A PATIENT WAS BEING MOVED, AN ASTRAL DEVICE DISPLAYED A LOW
BATTERY ALARM AND WOULD NOT CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT
RETURNED TO THE RESMED DESIGN HOUSE FOR AN INVESTIGATION. THE METHODS, RESULTS, AND
THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE DEVICE FAULT COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING. THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS
RESMED THAT A PATIENT HAD A HEAVY COUGH THAT ALLEGEDLY TRIGGERED AN ASTRAL DEVICE
TO ALARM. THE CAREGIVER CHOSE TO REMOVE THE PATIENT FROM THE DEVICE AND BEGIN
MANUAL VENTILATION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO RESMED FOR AN INVESTIGATION. THE
5933371||NOU|Continuous, Ventilator, Home Use|27023|ASTRAL 150 - EUR2|Malfunction|
Failure to Calibrate|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS
5933455||NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 - DEU|Malfunction|
5934562||NOU|Continuous, Ventilator, Home Use|27083|ASTRAL 150 - APAC1|Malfunction|
5934882||NOU|Continuous, Ventilator, Home Use|27072|ASTRAL 100 SGL KIT - FRA|
Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED A SYSTEM FAULT (SF 189). THIS RESULTED IN AN ALARM WHICH NOTIFIED THE
CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED.
THE REPORTED COMPLAINT WAS CONFIRMED THROUGH THE REVIEW OF THE DEVICE DATA LOGS.
THE EVALUATION DETERMINED THAT THE SYSTEM FAULT 189 WAS DUE TO A DEFECTIVE MAIN
PCB. THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT A SYSTEM FAULT 223
WAS OBSERVED ON AN ASTRAL DEVICE, INDICATING A POSITIVE END EXPIRATORY PRESSURE
(PEEP) BLOWER FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICES AND AN
EVALUATION WAS PERFORMED. THE SYSTEM TESTING PERFORMED BY THE TECHNICAL SERVICES
STAFF COULD NOT REPRODUCE THE FAULT. THE EVALUATION RESULTED IN "NO FAULT FOUND".
THE DEVICE WAS CLEANED, SERVICED, CALIBRATED AND TESTED BEFORE RETURNING TO THE
CUSTOMER RESMED REFERENCE #: (B)(4).
5945000||NOU|Continuous, Ventilator, Home Use|27063|ASTRAL 150 -EUR4|Malfunction|
DISPLAYED A SYSTEM FAULT (SF 189) ERROR MESSAGE INDICATING A LOSS OF COMMUNICATION.
THE ERROR MESSAGE DISPLAYED WAS DUE TO A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN
DISPLAYED A SYSTEM FAULT (SF 180) ERROR MESSAGE INDICATING A BATTERY CHARGER FAULT.
RETURNED TO THE RESMED AND AN EVALUATION WAS PERFORMED. THE REPORTED SYSTEM FAULT
180 WAS CONFIRMED THROUGH REVIEW OF THE DEVICE DATA LOGS. THE EVALUATION DETERMINED
THAT THE ERROR MESSAGE DISPLAYED WAS DUE TO A DEFECTIVE INTERNAL BATTERY. RESMED'S
5948248||NOU|Continuous, Ventilator, Home Use|27074|ASTRAL 150 DBL KIT - FRA|
DISPLAYED A SYSTEM FAULT MESSAGE (SF65). THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED FOR AN EXTENSIVE
ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 195) AND SYSTEM FAULT (SF 218) ERROR
MESSAGES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO THE RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
#: (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS DISPLAYING A DC
POWER INDICATOR EVEN THOUGH THE POWER SUPPLIED WAS AC. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY THE RESMED AND AN
RECOGNIZE THE CORRECT POWER SOURCE WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB).
INDICATING A SOFTWARE TASK ERROR FOLLOWED BY THE DEVICE PERFORMING A SAFETY RESET.
RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
#: (B)(4).
REPLACED TO ADDRESS THIS ISSUE. RESMED COMPLETED A RISK ANALYSIS FOR THIS FAILURE
MODE AND CONCLUDED THAT THE RISK IS ACCEPTABLE. (B)(4).
Failure to Calibrate|IT WAS REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS
BEING SERVICED IT FAILED TO COMPLETE ITS INTERNAL SELF TEST. THERE WAS NO PATIENT
INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE
ACCEPTABLE. (B)(4).
DISPLAYED A SYSTEM FAULT (SF 189) ERROR MESSAGE AND PERFORMED A SAFETY RESET. THE
DEVICE WORK NORMALLY AFTER THE SAFETY RESET. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE ERROR MESSAGE DISPLAYED WAS DUE
TO A FAULTY MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS
ASTRAL DEVICE DISPLAYED SYSTEM FAULTS (SF 179 AND SF 218). THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR
Device Inoperable;Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD
A POWER SOURCE DETECTION ERROR AND SUBSEQUENTLY AN UNRESPONSIVE TOUCHSCREEN WHEN
THE DEVICE WAS BEING CHECKED BY THE MEDICAL EQUIPMENT TECHNICIAN. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE POWER
SOURCE DETECTION ERROR WAS CAUSED BY A FAULTY POWER CONNECTOR AT CUSTOMER SITE. THE
UNRESPONSIVE TOUCHSCREEN ERROR COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE
DEVICE PERFORMED TO SPECIFICATIONS. THE DEVICE WAS SERVICED AND RETURNED TO THE
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DID NOT
RECOGNIZE WHEN AN EXTERNAL BATTERY PACK POWER SOURCE WAS CONNECTED. THE DEVICE
CONTINUED TO OPERATE USING ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN
THIS STAGE. (B)(4).
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED. THE METHODS, RESULTS
AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).
DISPLAYED A SYSTEM FAULT MESSAGE (SF65) INDICATING A DATA ISSUE. THERE WAS NO
THE RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE
SYSTEM FAULT 65 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE
TESTING. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS
5984313||NOU|Continuous, Ventilator, Home Use|27093|ASTRAL 150 - FUKUDA|
Device Displays Incorrect Message;Device Stops Intermittently|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE ALARM WAS TRIGGERED. THE ALARM RESULTED IN AN
OF THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS
ATTEMPTED TO MAKE CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION, HOWEVER, NO
CONTACT HAS BEEN MADE. (B)(4).
Device Stops Intermittently|IT WAS REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE
WAS BEING CONFIGURED FOR A PATIENT IT FAILED TO TURN ON. THERE WAS NO PATIENT
TURN ON WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD. THE MAIN CIRCUIT BOARD WAS
REPORTED TO RESMED THAT WHILE AN ASTRAL DEVICE WAS BEING SERVICED AN ALARM WAS
TRIGGERED. THE ALARM RESULTED IN AN UNEXPECTED RESTART OF THE DEVICE AND AN ERROR
MESSAGE WAS DISPLAYED. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED,
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND
AN EVALUATION WAS PERFORMED. THE FAULT WAS NOT REPRODUCIBLE DURING IN HOUSE TESTING
AND THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS SERVICED,
CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S
RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4.
ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF101 AND 218). THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE ERROR MESSAGES WERE
DUE WATER DAMAGE OF THE PNEUMATIC BLOCK AND EXPIRATORY FLOW SENSOR. THE DEVICE WAS
. RESMED REFERENCE #: (B)(4).
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF138). THERE WAS NO PATIENT INJURY
RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS,
(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN
INOPERABLE BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE FAULT WAS DUE TO A DEFECTIVE BATTERY. THE BATTERY
ABLE TO DETECT THE POWER SOURCE SUPPLIED. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE IS CURRENTLY BEING RETURNED TO RESMED FOR AN
Failure to Calibrate|IT WAS REPORTED TO RESMED THAT DURING THE ROUTINE SERVICING OF
AN ASTRAL DEVICE IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT
No Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN
UNRESPONSIVE TOUCHSCREEN WHEN THE DEVICE WAS BEING CONFIGURED FOR A PATIENT. THERE
RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT
THE DEVICE PERFORMED TO SPECIFICATIONS. THE TOUCHSCREEN WAS FULLY RESPONSIVE
THROUGHOUT THE EVALUATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.
(B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT WHEN AN ASTRAL DEVICE WAS CONNECTED TO
AC POWER IT DETECTED THE SOURCE TO BE A DC POWER SOURCE. THERE WAS NO PATIENT
ACCURATELY DETECT THE POWER SOURCE WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB).
DISPLAYED PRESSURE WARNING ALARMS. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
PERFORMED. THE EVALUATION DETERMINED THAT THE WARNING ALARMS WERE DUE TO A
(B)(4).
No Display / Image|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD AN UNRESPONSIVE
TOUCHSCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DETERMINED THAT THE TOUCH SCREEN FAILURE WAS DUE TO A DEFECTIVE TOP COVER. THE TOP
COVER PANEL WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN INVESTIGATION
WAS PERFORMED. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
6050427|20161001|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50|No
answer provided|Improper Alarm;Delayed Alarm|HOSPITAL IN (B)(6) REPORTS A PROBLEM
ENCOUNTERED WITH A VIVO 50 VENTILATOR IN A HOMECARE ENVIRONMENT, STATING: "THE
ALARM FOR [PATIENT] DISCONNECTION DOES NOT ALWAYS TRIGGER AS EXPECTED. DURING
TESTING, A 40-SECOND DELAY HAS BEEN OBSERVED" [TRANSLATED FROM (B)(6)]. THE
REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT, BUT
IF THE SITUATION WERE TO RECUR, IT MIGHT POTENTIALLY RESULT IN SERIOUS INJURY, IF
PHYSIOLOGICAL ALARM SETTINGS ARE NOT PROPERLY USED. BASED ON THE INFORMATION
PROVIDED AT THIS TIME, INDICATING A USE ERROR, THE REPORTED EVENT IS CONSIDERED
REPORTABLE PER 21 CFR PART 803.3.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS
CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.
Inappropriate or Unexpected Reset;Device Displays Incorrect Message|IT WAS REPORTED
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A
SOFTWARE TASK FAULT WHICH RESULTED IN A SAFETY RESET. THERE WAS NO PATIENT INJURY
INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE
OCCURRENCE OF SYSTEM FAULT 74 FOLLOWED BY AN UNEXPECTED RESTART. THE INVESTIGATION
COULD NOT REPRODUCE THESE EVENTS DURING IN-HOUSE TESTING. BASED ON THE
INVESTIGATION RESULTS AND PREVIOUS INVETIGATIONS OF SIMILAR COMPLAINTS, IT WAS
DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A SOFTWARE ISSUE. TO RESOLVE THIS
ISSUE, THE DEVICE SOFTWARE WAS UPGRADED. THE DEVICE WAS CLEANED, SERVICED,
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN SF180 ERROR MESSAGE INDICATING A
BATTERY CHARGER FAULT. THE DEVICE ALSO FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO PATIENT
INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED.
REVIEW OF THE DEVICE LOGS DETERMINED THAT THE ERROR MESSAGE SF180 WAS A SINGLE
OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE EVALUATION ALSO
DEFECTIVE PNEUMATIC BLOCK. THE BATTERY AND THE PNEUMATIC BLOCK WERE REPLACED TO
ADDRESS THESE ISSUES. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT WHEN AN ASTRAL DEVICE WAS
CONNECTED TO AC POWER IT DETECTED THE SOURCE TO BE A DC POWER SOURCE WHICH RESULTED
IN A LOW INTERNAL BATTERY ALARM TO BE TRIGGERED. THERE WAS NO PATIENT INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE
NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED
Charging Problem;Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
INTERNAL BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS
PERFORMED. REVIEW OF THE DEVICE LOGS REVEALED THAT BATTERY ALARMS WERE TRIGGERED
DUE TO A DEPLETED BATTERY. IN-HOUSE TESTING SHOWED THAT THE BATTERY CHARGED
NORMALLY AND THE DEVICE MET SERVICE SPECIFICATIONS. THE DEVICE WAS SERVICED,
CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S
(4).
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|THE DEVICE WAS RETURNED TO THE RESMED AND AN EVALUATION WAS PERFORMED.
PERFORMANCE TESTING CONFIRMED THE REPORTED FAILURE. THE INVESTIGATION METHODS
RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE#: (B)(4).
6073644||NOU|Continuous, Ventilator, Home Use|27064|ASTRAL 150 DBL KIT - EUR4|
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF65) INDICATING THE PROGRAM DATA WAS
CORRUPTED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION
DETERMINED THAT THE SYSTEM FAULT 65 WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD
(PCB). THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR
(4).
Inappropriate or Unexpected Reset|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
HAD A POWER FAILURE AND UNEXPECTEDLY RESTARTED. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. IT WAS OBSERVED THAT AN ERROR MESSAGE "BATTERY NOT
WORKING" WAS DISPLAYED IN THE DEVICE. REVIEW OF THE DEVICE LOGS SHOWED AN
OCCURRENCE OF "BATTERY COMMS LOST" ERROR FOLLOWED BY A POWER FAILURE AND AN
UNEXPECTED RESET. THE EVALUATION DETERMINED THAT THE REPORTED FAILURE WAS DUE TO AN
ISOLATED SOFTWARE ISSUE. THE SOFTWARE WAS UPGRADED TO ADDRESS THIS ISSUE. RESMED'S
(4).
Malfunction|Power Problem|IT WAS REPORTED BY THE RESMED SERVICE CENTER THAT AN
ASTRAL DEVICE WAS DETECTING THE MAIN POWER SUPPLY AS AN EXTERNAL BATTERY. THE
DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO PATIENT
INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED FOR GENERAL MAINTENANCE AND DURING
EVALUATION, THE REPORTED POWER ISSUE WAS OBSERVED. IT WAS DETERMINED THAT THE
DEVICE FAILURE TO ACCURATELY DETECT THE POWER SOURCE WAS DUE TO A DEFECTIVE MAIN
Malfunction|Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
FAILED TO TURN ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE DEVICE FAILURE TO TURN ON WAS DUE TO A DEFECTIVE
DETECTING THE MAIN POWER SUPPLY AS AN EXTERNAL BATTERY. THERE WAS NO PATIENT INJURY
COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED
THEREFORE THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND
No Audible Alarm;Inappropriate or Unexpected Reset|IT WAS REPORTED TO RESMED THAT
AN ASTRAL DEVICE SHUT DOWN WITHOUT PRIOR WARNING ALARMS. THERE WAS NO PATIENT
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE REPORTED ISSUE WAS
DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 223) AND
SUBSEQUENTLY STOPPED VENTILATING. PER THE REPORTER, THE PATIENT WAS MANUALLY
VENTILATED UNTIL THE PATIENT WAS RECEIVED AT A CARE FACILITY AND PLACED ON ANOTHER
VENTILATOR. THERE WAS NO SERIOUS PATIENT INJURY REPORTED AS A RESULT OF THIS
SYSTEM FAULT 223 (SF223) INDICATED A FAILURE IN THE PEEP MOTOR IN THE PNEUMATIC
BLOCK. THE EVALUATION DETERMINED THAT THE ERROR MESSAGE AND SUBSEQUENT DEVICE SHUT
DOWN WERE DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
DISPLAYED AN ERROR MESSAGE (SF 200). THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS
PERFORMED. THE EVALUATION CONFIRMED THAT ERROR MESSAGE SF200, INDICATING THE BLOWER
TEMPERATURE SENSOR WAS DISCONNECTED, OCCURRED IN THE DEVICE. IT WAS DETERMINED THAT
THE REPORTED ISSUE WAS DUE TO A DEFECTIVE BLOWER. THE BLOWER WAS REPLACED TO
6083876||NOU|Continuous, Ventilator, Home Use|27083|ASTRAL 150 - APAC|Malfunction|
Device Displays Incorrect Message;Inappropriate or Unexpected Reset|IT WAS REPORTED
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 101) AND STOPPED
VENTILATING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
DETECTING THE MAIN POWER SUPPLY AS AN EXTERNAL BATTERY. THERE WAS NO PATIENT INJURY
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF74), INDICATING A
SOFTWARE TASK FAULT, BEFORE STOPPING VENTILATION AND RESETTING. THERE WAS NO
(4).
Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD NO POWER.
RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION REVEALED THAT
THE INTERNAL BATTERY WAS NOT CHARGING AND A "BATTERY INOPERABLE" ALARM WAS
TRIGGERED. IT WAS DETERMINED THAT THE DEVICE FAILURE TO CHARGE ITS INTERNAL BATTERY
WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO
6091596||NOU|Continuous, Ventilator, Home Use|27943|PSU - ASTRAL|Malfunction|Power
Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY UNIT (PSU) WAS
DEFECTIVE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
CONFIRMED THAT THE PSU WAS DEFECTIVE. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE.
PSU DEFECT WAS DUE TO AN ISOLATED COMPONENT FAILURE. RESMED'S RISK ANALYSIS FOR
Device Inoperable;Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT
AN ASTRAL DEVICE WAS ALARMING AND UNRESPONSIVE. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE INOPERABLE DEVICE WAS
DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO ADDRESS
CONFIRMED THAT THE POWER SUPPLY UNIT (PSU) WAS INOPERABLE. BASED ON THE EVALUATION
RESULTS AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT
THE REPORTED PSU DEFECT WAS DUE TO AN ISOLATED COMPONENT FAILURE. THE PSU WAS
Battery Problem;Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
INTERNAL BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO CHARGE ITS INTERNAL
BATTERY WAS DUE TO A DEFECTIVE MAIN PRINTED CIRCUIT BOARD (PCB). THE MAIN PCB WAS
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES AND SUBSEQUENTLY
STOPPED VENTILATING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT. PER THE REPORTER, "WHEN THE AIR TUBING WAS DISCONNECTED FROM THE
HUMIDIFIER TO REMOVE WATER CONDENSATION IN THE CIRCUIT, THE SCREEN BECAME RED AND
THE VENTILATION STOPPED." THE PATIENT WAS MANUALLY VENTILATED UNTIL THE DEVICE
RESTARTED.|THE DEVICE EVENT LOG WAS PROVIDED TO RESMED FOR REVIEW. REVIEW OF THE
EVENT LOG SHOWED THAT THE REPORTED ISSUES HAVE OCCURRED. RESMED HAS REQUESTED FOR
OCCURRENCE OF A MALFUNCTION AT THIS TIME. (B)(4).
6097442||NOU|Continuous, Ventilator, Home Use|27918|BATTERIE EXTERNE ASTRAL|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO
RECOGNIZE THE EXTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY UNIT (PSU) HAD NO
POWER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE POWER
SUPPLY UNIT (PSU) WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE
EVALUATION CONFIRMED THAT THE PSU WAS NOT FUNCTIONING. THE PSU WAS REPLACED TO
ADDRESS THIS ISSUE... RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT
DISPLAYED AN ERROR MESSAGE (SF197). THE DEVICE WAS NOT IN USE WHEN THE FAULT
OCCURRED THEREFORE THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO
RESMED AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE
OCCURRENCE OF ERROR MESSAGE SF197 INDICATING THE OUTLET FLOW SENSOR WAS STUCK. THE
DISPLAYED AN ERROR MESSAGE (SF101) WHILE IN USE BY A PATIENT. THERE WAS NO PATIENT
Device Stops Intermittently|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE SHUT
DOWN UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE DEVICE SHUT DOWN WAS DUE TO A DEFECTIVE INTERNAL
BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. (B)(4).
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
answer provided|Device Operational Issue|HEALTHCARE FACILITY IN THE (B)(6) REPORTS
A PROBLEM ENCOUNTERED WITH A BREAS VIVO 50 VENTILATOR DURING TREATMENT. PER THE
INITIAL REPORTER: "THE VENTILATOR WAS DISCOVERED TO HAVE TURNED OFF FOR A PERIOD OF
38 MINUTES. STAFF HAD TO PHYSICALLY TURN THE MACHINE BACK ON. THE RESIDENT DID NOT
COME TO HARM. VENTILATOR TAKEN OUT OF USE AND ENGINEER CONTACTED TO CHECK THE
MACHINE. THIS WAS TAKEN AWAY BY DEVA MEDICAL AND CHECKED. THEY COMPLETED ALL CHECKS
AND THEY COULD FIND NO FAULT WITH THE MACHINE. THE HISTORY DISPLAY SHOWS THAT
TREATMENT WAS STOPPED AT 18.16 AND THEN RESTARTED AT 18.59. A FULL INVESTIGATION
HAS TAKEN PLACE AND THE OUTCOME WAS THAT THE MACHINE HAS AN INTERMITTENT FAULT, AS
IT HAD DONE THIS AT LEAST ONCE BEFORE. A DELIBERATE ACT OF TURNING OFF THE
VENTILATOR HAS BEEN RULED OUT." THE REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS
A RESULT OF THE REPORTED EVENT, BUT IF THE SITUATION WERE TO RECUR, IT MIGHT
POTENTIALLY RESULT IN SERIOUS INJURY. AT THIS POINT, THE INITIAL REPORTER ALSO
CONCLUDED "INTERMITTENT FAULT COULD NOT BE RULED OUT, NEITHER COULD HUMAN
INTERVENTION" AFTER THEIR CONTRACTED SERVICE PARTNER DEVA COULD NOT FIND ANYTHING
WRONG WITH THE DEVICE - THE DEVICE PASSED ALL ITS TESTS. BASED ON THE INFORMATION
PROVIDED AT THIS TIME, INCLUDING INVESTIGATION RESULTS INDICATING A USE ERROR, THE
REPORTED EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|
No Display / Image|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE ALARMED AND THE
TOUCHSCREEN WAS INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED.
REVIEW OF THE ALARM EVENTS LOG IN THE DEVICE DID NOT SHOW ANY ALARMS RELATED TO THE
REPORTED ISSUE. THE EVALUATION FOUND THAT THE TOUCH SCREEN WAS RESPONSIVE AND THE
DEVICE PERFORMED TO SPECIFICATIONS. THE DEVICE WAS SERVICED AND RETURNED TO THE
ACCEPTABLE. (B)(4).
Device Displays Incorrect Message;Power Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE WAS INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|PER THE REPORTER, THE ASTRAL DEVICE WAS IN STORAGE WITH A NOTE
STATING THE DEVICE WAS INOPERABLE. THE CUSTOMER CONTACTED RESMED TO REQUEST
ASSISTANCE TROUBLESHOOTING THE ASTRAL DEVICE. DURING TROUBLESHOOTING, THE CUSTOMER
STATED THAT THE INTERNAL BATTERY WAS DEPLETED AND THE DEVICE DISPLAYED AN ERROR
MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT. THE DEVICE WAS RECEIVED BY RESMED
AND AN EVALUATION WAS PERFORMED. THE BATTERY TESTING DID NOT FIND ANY FAULT WITH
THE INTERNAL BATTERY. REVIEW OF THE DEVICE LOG SHOWED A SINGLE OCCURENCE OF SYSTEM
FAULT 74, HOWEVER, THE FAULT COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE
SOFTWARE WAS UPGRADED TO ADDRESS THE SF74 ISSUE. THE DEVICE WAS SERVICED, CLEANED,
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL BATTERY HAD
SHOWN EVIDENCE OF MELTING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
RECOGNIZING THE AC POWER SUPPLY AS A DC POWER SOURCE. THERE WAS NO PATIENT INJURY
MALFUNCTION AT THIS TIME. THE REPORTABLE EVENT OCCURRED OUTSIDE THE US AND WAS
ASSESSED AS NOT REPORTABLE IN (B)(6).Â DURING A ROUTINE CHECK OF COMPLAINTS
RECORDS IT WAS DETECTED THAT THE EVENT IS REPORTABLE IN THE US.Â THIS REPORT IS
BEING SUBMITTED TO CORRECT THE ERROR. RESMED REFERENCE #: (B)(4).
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT.
THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO PATIENT
INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE
NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE WAS SERVICED, CLEANED,
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. THE
REPORTABLE EVENT OCCURRED OUTSIDE THE US AND WAS ASSESSED AS NOT REPORTABLE IN (B)
(6). DURING A ROUTINE CHECK OF COMPLAINTS RECORDS IT WAS DETECTED THAT THE EVENT IS
REPORTABLE IN THE US. THIS REPORT IS BEING SUBMITTED TO CORRECT THE ERROR. (B)(4).
ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF74, SF195 AND SF218). THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE
MALFUNCTION AT THIS TIME. (B)(4). THE REPORTABLE EVENT OCCURRED OUTSIDE THE US.
DURING A ROUTINE CHECK OF COMPLAINTS RECORDS IT WAS DETECTED THAT THE EVENT IS
REPORTABLE IN THE US AND WAS ASSESSED AS NOT REPORTABLE IN. THIS REPORT IS BEING
SUBMITTED TO CORRECT THE ERROR.
MALFUNCTION AT THIS TIME. (B)(4). THE REPORTABLE EVENT OCCURRED OUTSIDE THE US.
DURING A ROUTINE CHECK OF COMPLAINTS RECORDS IT WAS DETECTED THAT THE EVENT IS
REPORTABLE IN THE US AND WAS ASSESSED AS NOT REPORTABLE IN JAPAN. THIS REPORT IS
BEING SUBMITTED TO CORRECT THE ERROR.
6134011||NOU|Continuous, Ventilator, Home Use|27003|ASTRAL 150 - AMER|Death|Data
Problem|IT WAS REPORTED TO RESMED THAT A PATIENT EXPERIENCING STOMACH PAIN HAD
EXPIRED WHILE USING AN ASTRAL DEVICE.|THE DEVICE WAS RETURNED TO RESMED FOR AN
Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A FAULTY
POWER ON BUTTON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE REPORTED FAULT WAS DUE TO A FAULTY SWITCH. THE
DEVICE CHASSIS WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
DISPLAYED AN ERROR MESSAGE (SF147) INDICATING A MAIN BLOWER FAILURE. THERE WAS NO
(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS NOT CHARGING.
RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION FOUND THAT THE
DEVICE WAS DETECTING THE MAIN POWER SUPPLY AS AN EXTERNAL POWER SOURCE AND NOT
CHANGING THE INTERNAL BATTERY. IT WAS DETERMINED THAT THE DEVICE FAILURE TO
INTERMITTENTLY INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION CONFIRMED THAT THE PSU WAS DEFECTIVE. THE PSU WAS REPLACED TO ADDRESS
THIS ISSUE. BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS
DETERMINED THAT THE PSU DEFECT WAS DUE TO AN ISOLATED COMPONENT FAILURE. RESMED'S
CONFIRMED THAT THE PSU WAS DEFECTIVE. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE.
PSU DEFECT WAS DUE TO AN ISOLATED COMPONENT FAILURE. RESMED'S RISK ANALYSIS FOR
(4).
Device Stops Intermittently;Device Displays Incorrect Message|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF101) AND THE VENTILATION
STOPPED WHILE TRAVELING IN A CAR. PER THE REPORTER, THE PATIENT WAS MANUALLY
VENTILATED UNTIL THE DEVICE WAS REBOOTED. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE
6143423||NOU|Continuous, Ventilator, Home Use|27919|ASTRAL EXTERNAL BATTERY,
AMERICAS|Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
EXTERNAL BATTERY WAS NOT PROVIDING POWER. THERE WAS NO PATIENT INJURY REPORTED AS A
PERFORMED. THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING AND
THE DEVICE OPERATED PER SPECIFICATIONS. RESMED'S RISK ANALYSIS FOR THESE FAILURE
Device Displays Incorrect Message;No Display / Image|IT WAS REPORTED TO RESMED THAT
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF101 AND SF218 ) AND THE TOUCH SCREEN
WAS SPORADICALLY UNRESPONSIVE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED.
THE EVALUATION DETERMINED THAT THE ERROR MESSAGES AND DISPLAY FAILURE WERE DUE TO A
(B)(4).
DISPLAYED AN ERROR MESSAGE (SF65). THE DEVICE WAS NOT IN USE WHEN THE FAULT
RESMED AND AN EVALUATION WAS PERFORMED. THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF
A SYSTEM FAULT 65 INDICATING THE PROGRAM DATA WAS CORRUPTED. BASED ON THE
EVALUATION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED
THAT THE SYSTEM FAULT WAS DUE TO AN ISOLATED SOFTWARE ERROR. THE DEVICE WAS
DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT AND TRIGGERED A
SAFETY RESET ALARM. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RECEIVED BY RESMED AND AN
EVALUATION WAS PERFORMED. THE EVALUATION REVEALED A SINGLE OCCURRENCE OF SYSTEM
FAULT 74 AND THE ISSUE COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. BASED ON
PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE ALARMS
WERE DUE TO A SOFTWARE ISSUE. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND
DETERMINED THAT THE DEVICE FAILURE TO FUNCTION WAS DUE TO A DEFECTIVE MAIN CIRCUIT
Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO POWER
ON. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
Power Problem;Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS
THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION
SHOWED THAT THE INTERNAL BATTERY HAD A CRITICALLY LOW CHARGE, HOWEVER, BATTERY
TESTING FOUND NO ISSUES WITH THE BATTERY. IT WAS DETERMINED THAT THE CHARGING ISSUE
WAS DUE TO A DEPLETED BATTERY. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS
ACCEPTABLE. (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS HAVING POWER
ISSUES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE SERVICE CENTER
WAS UNABLE TO COMPLETE THE EVALUATION DUE TO INSECT INFESTATION IN THE DEVICE.
BASED ON SIMILAR INVESTIGATIONS, A FAULT FROM INSECT CONTAMINATION CAN CAUSE POWER
SUPPLY TO BE SHORT TO GROUND. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
DEVICE IS NOT CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A BATTERY THAT
FAILED TO HOLD CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
DEVICE STARTED UP THEN SUBSEQUENTLY STOPPED VENTILATION. THERE WAS NO PATIENT
ASTRAL DEVICE STARTED UP AND SUBSEQUENTLY STOPPED VENTILATION. THERE WAS NO PATIENT
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY
UNIT (PSU) WAS DEFECTIVE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK AND MAIN CIRCUIT BOARD.
THE PNEUMATIC BLOCK AND MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF189).
RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION
Malfunction|Loss of Power|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A
TOTAL POWER FAILURE DURING VENTILATION. THERE WAS NO PATIENT INJURY REPORTED AS A
TIME. (B)(4).
WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF101) AND
SUBSEQUENTLY SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
#: (B)(4).
6164937||NOU|Continuous, Ventilator, Home Use|19620|BATTERIE INTERNE - ASTRAL|
INTERNAL BATTERY FAILED TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN
AMERICAS|Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
EXTERNAL BATTERY WAS DEFECTIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED
THEREFORE THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS NOT RETURNED TO RESMED
FOR EVALUATION, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT
THIS TIME. (B)(4).
6164979||NOU|Continuous, Ventilator, Home Use|27918|ASTRAL EXTERNAL BATTERY, ROW|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL EXTERNAL BATTERY
WAS ONLY ABLE TO POWER THE DEVICE FOR 1 HOUR. THERE WAS NO PATIENT INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR EVALUATION. THE
EVALUATION CONFIRMED THE REPORTED BATTERY ISSUE. BASED ON THE EVALUATION RESULTS
AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE
BATTERY FAULT WAS DUE TO AN ISOLATED COMPONENT FAILURE IN THE EXTERNAL BATTERY
ASSEMBLY. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
(B)(4).
TO RESMED THAT AN ASTRAL DEVICE ALARMED AND THE TOUCH SCREEN WAS INOPERABLE. THERE
WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED
FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE
PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO
Inappropriate or Unexpected Reset;No Audible Alarm|IT WAS REPORTED TO RESMED THAT
AN ASTRAL DEVICE SHUT DOWN WITHOUT PRIOR WARNING ALARMS. THERE WAS NO PATIENT
DISPLAYED AN ERROR MESSAGE (SF191). THERE WAS NO PATIENT INJURY REPORTED AS A
INTERNAL SELF-TEST WAS DUE TO SOFTWARE ISSUE. THE SOFTWARE WAS UPDATED TO ADDRESS
ACCEPTABLE. (B)(4).
ACCEPTABLE. (B)(4).
INTERNAL SELF-TEST WAS DUE TO SOFTWARE ISSUE. DEVICE SOFTWARE WAS UPDATED TO
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF180) INDICATING A BATTERY CHARGER
(4).
AMERICAS|Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
EXTERNAL BATTERY IS DEFECTIVE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS
ATTEMPTED TO CONTACT THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION REGARDING THE
COMPLAINT, HOWEVER, NO CONTACT HAS BEEN MADE. RESMED REFERENCE #: (B)(4).
DETECTING THE MAIN POWER SUPPLY UNIT (PSU) AS AN EXTERNAL BATTERY. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE
FAILURE TO ACCURATELY DETECT THE POWER SOURCE WAS DUE TO A DEFECTIVE MAIN CIRCUIT
Device Alarm System|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DID NOT ALARM.
THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS
REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN EVALUATION COULD BE PERFORMED.
ALLEGED MALFUNCTION AT THIS TIME.
ASTRAL DEVICE TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO PATIENT INJURY REPORTED AS
PERFORMED. PERFORMANCE TESTING OF THE DEVICE COULD NOT REPRODUCE THE REPORTED
ISSUE. THE DEVICE WAS SERVICED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED REFERENCE #: (B)(4).
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN
CONCLUSION ARE NOT FINALIZED AT THIS STAGE.(B)(4).
PERFORMED. REVIEW OF THE DEVICE LOGS FOUND A SINGLE OCCURRENCE OF SYSTEM FAULT 179,
INDICATING A CAPACITOR FAULT. HOWEVER, THE REPORTED FAILURE COULD NOT BE REPRODUCED
DURING IN-HOUSE TESTING AND THE DEVICE OPERATED PER SPECIFICATIONS. THE DEVICE WAS
ACCEPTABLE. (B)(4).
POWER SUPPLY WAS RETURNED TO THE RESMED AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE POWER SUPPLY WAS DEFECTIVE. THE POWER SUPPLY WAS
PERFORMED. THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING AND
THE DEVICE OPERATED PER SPECIFICATIONS. THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS
REPLACED AS PART OF GENERAL SERVICE, THEN IT WAS CALIBRATED AND TESTED BEFORE IT
WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
PERFORMED. IN-HOUSE TESTING WAS NOT ABLE TO REPRODUCE THE INTERNAL SELF-TEST
FAILURE. DURING EVALUATION, THE DEVICE FAILED THE MAIN BLOWER TEST. THE PNEUMATIC
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE SOFTWARE WAS UPDATED TO
PERFORMED. THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS NOT CONFIRMED.
DURING IN-HOUSE TESTING, IT WAS FOUND THAT THE DEVICE FAILED THE BLOWER TEST. THE
PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.RESMED'S RISK ANALYSIS FOR THIS
FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4).
DISPLAYED A SYSTEM FAULT 101 (SF101) ERROR MESSAGE. THERE WAS NO PATIENT INJURY
THIS STAGE. (B)(4).
DISPLAYED AN UNKNOWN SYSTEM FAULT ERROR MESSAGE. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. THE EVALUATION FOUND THAT A SYSTEM FAULT 74, INDICATING A
SOFTWARE TASK ERROR, OCCURRED IN THE DEVICE DURING A SOFTWARE UPGRADE. THE SOFTWARE
WAS UPDATED AND THE DEVICE WAS SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK
Failure to Calibrate;Device Displays Incorrect Message;Battery Problem|IT WAS
REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY DEGRADED" ALARM AND
PERFORMED. THE BATTERY EVALUATION FOUND THAT THE BATTERY WAS DEGRADED DUE TO NORMAL
USAGE. THE BATTERY WAS REPLACED AS PART OF THE GENERAL SERVICE. ALSO, THE
ACCEPTABLE. (B)(4).
6194211||NOU|Continuous, Ventilator, Home Use|27003|ASTRAL 150 - AMER|Death|Adverse
Event Without Identified Device or Use Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL PATIENT WAS FOUND UNCONSCIOUS AND APPEARED TO BE NOT BREATHING. THE PATIENT
WAS MANUALLY VENTILATED THEN TAKEN TO THE HOSPITAL. THE PATIENT EXPIRED IN THE
HOSPITAL 3 DAYS AFTER THE EVENT. THE PATIENT WAS NOT ON THE DEVICE AT THE TIME OF
THE DEATH. IT WAS REPORTED THE DEVICE WAS ALARMING WHEN THE PATIENT WAS FOUND.|THE
DEVICE WAS RECEIVED BY RESMED AND AN ENGINEERING INVESTIGATION WAS PERFORMED. A
REVIEW OF THE DEVICE DATA LOGS SHOWS THAT A PRESSURE ALARM AND PATIENT CIRCUIT
DISCONNECTION ALARM WERE TRIGGERED, NOTIFYING THE CAREGIVER OF THE EVENT. THE
DEVICE WAS THOROUGHLY TESTED BY THE RESMED DESIGN HOUSE LOCATED IN (B)(4). BASED ON
THE TESTING, AS WELL AS A REVIEW OF THE DEVICE LOGS, NO FAULT WAS FOUND. THE
DETAILS OF THE EVENT WERE REVIEWED BY RESMED'S CHIEF MEDICAL OFFICER, DR. (B)(4).
BASED ON DR. (B)(4) REVIEW, THERE WAS NO INDICATION THAT THE DEVICE CONTRIBUTED TO
THE PATIENT'S HOSPITALIZATION AND SUBSEQUENT DEATH.Â¿ (B)(4).
Battery Problem|AN ASTRAL DEVICE WAS RETURNED TO RESMED FOR ROUTINE SERVICING.
THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING THE EVALUATION OF THE DEVICE
AT THE RESMED SERVICE CENTER, THE DEVICE FAILED TO PASS THE INTERNAL BATTERY
PERFORMANCE TEST. THE DEVICE WAS NOT IN USE THEREFORE, THERE WAS NO PATIENT
EVALUATION DETERMINED THAT THE DEVICE FAILURE TO PASS THE INTERNAL BATTERY
PERFORMANCE TEST WAS DUE TO BATTERY DEGRADATION. THE INTERNAL BATTERY WAS REPLACED
Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT A SYSTEM FAULT (SF
101) OCCURRED ON AN ASTRAL DEVICE WHICH RESULTED IN AN ALARM NOTIFYING THE USER OF
THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE SYSTEM FAULT 101 WAS DUE TO A SOFTWARE ISSUE. THE
DEVICE WAS SERVICED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THESE FAILURE
Calibration Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE WAS SERVICED TO ADDRESS
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE SOFTWARE WAS UPGRADED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED SYSTEM FAULT (SF 218 AND 197) ERROR
MESSAGES. IT WAS ALSO REPORTED THAT THE DEVICE STOPPED DELIVERING THERAPY WITH AN
ALARM TO WARN THE USER ABOUT THE STOP IN VENTILATION. THE PATIENT WAS MANUALLY
VENTILATED AND PLACED ON A BACK-UP VENTILATOR WITH NO COMPLICATIONS. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE
REPORTED ISSUE. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A
DEFECTIVE FLOW SENSOR WITHIN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED
TO ADDRESS THIS ISSUE. RESMED REFERENCE #: (B)(4).
DISPLAYED ALARMED WITH AN ERROR MESSAGE (SF137). THERE WAS NO PATIENT INJURY
SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. BASED ON
PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE SYSTEM
FAULT WAS DUE TO AN ISOLATED SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THE SYSTEM FAULT
74 OCCURRED HOWEVER, IT COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THE DEVICE
WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED
WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO CHARGE ITS
INTERNAL BATTERY WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT WHEN AN ASTRAL DEVICE WAS
CONNECTED TO AC POWER IT DETECTED THE SOURCE TO BE A DC POWER SOURCE. THERE WAS NO
Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE'S BATTERY FAILED
TO CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS ATTEMPTED TO MAKE
CONTACT WITH THE CUSTOMER FOR FURTHER INFORMATION REGARDING THE DEVICE EVALUATION,
HOWEVER, NO CONTACT HAS BEEN MADE. (B)(4).
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT (SF 188) ERROR MESSAGE INDICATING A SAFETY
ASSERT FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE
(4).
THE MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. THE REPORTABLE EVENT OCCURRED
OUTSIDE THE US.Â DURING A ROUTINE CHECK OF COMPLAINTS RECORDS IT WAS DETECTED THAT
THE EVENT IS REPORTABLE IN THE US.Â THIS REPORT IS BEING SUBMITTED TO CORRECT THE
ERROR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 197 ) INDICATING AN OUTLET FLOW SENSOR
ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
STOPPED VENTILATING AND DISPLAYED AN ERROR MESSAGE (SF 101 ) INDICATING A PRESSURE
MEASUREMENT ERROR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED
ASTRAL DEVICE BY RESMED. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE OCCURRENCE OF
SYSTEM FAULT 101, HOWEVER, PERFORMANCE TESTING COULD NOT REPRODUCE THE REPORTED
FAULT. THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE WAS DUE TO A SOFTWARE
ACCEPTABLE. (B)(4).
Device Displays Incorrect Message;Failure to Calibrate|IT WAS REPORTED TO RESMED
THAT AN ASTRAL DEVICE WAS ALARMING AND FAILED TO COMPLETE ITS INTERNAL SELF-TEST.
RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS
CONFIRMED THE REPORTED DEVICE FAILURES. THE EVALUATION DETERMINED THAT THE ALARM
AND THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WERE DUE TO CONTAMINATION
AND WATER INGRESS WITHIN THE DEVICE. THE DEVICE WAS SERVICED, CALIBRATED, AND
DISPLAYED AN ERROR MESSAGE (SF 191) INDICATING A LOSS OF COMMUNICATION WITH THE
OUTLET FLOW SENSOR. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INCIDENT.|RESMED HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT
AS WELL AS THE RETURN OF THE DEVICE. THE DEVICE HAS NOT YET BEEN RETURNED,
THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED
Failure to Calibrate|IT WAS REPORTED TO RESMED THAT PRIOR TO AN ASTRAL DEVICE BEING
PLACED ON A PATIENT IT FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO
Malfunction|Charging Problem|IT WAS REPORTED BY RESMED THAT AN ASTRAL DEVICE FAILED
TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE
ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE DATA LOGS CONFIRMED
THE DEVICE FAILURE TO CHARGE ITS INTERNAL BATTERY. THE DEVICE EVALUATION FOUND THAT
THE DEVICE WAS DETECTING THE AC POWER AS A DC POWER SOURCE WHICH LED TO THE
INTERNAL BATTERY TO NOT BE CHARGED. THE INVESTIGATION DETERMINED THAT THE DEVICE
FAILURE TO RECOGNIZE THE CORRECT POWER SOURCE WAS DUE TO AN ISOLATED COMPONENT
FAILURE WITHIN THE DEVICE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED TO
ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE
6239589||NOU|Continuous, Ventilator, Home Use|27062|ASTRAL 100 SGL KIT - EUR4|
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF223). THERE WAS NO PATIENT INJURY
EVALUATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT
THIS STAGE. (B)(4).
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED THAT WHILE A TECHNICIAN
WAS PREPARING AN ASTRAL DEVICE FOR A PATIENT THE DEVICE HAD AN UNRESPONSIVE
ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS
PERFORMED. THE DEVICE EVALUATION FOUND THAT THE DEVICE WAS OPERATING ACCORDING TO
SPECIFICATION. PERFORMANCE TESTING COULD NOT REPRODUCE THE REPORTED SCREEN FAILURE.
BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND THE AVAILABLE
INFORMATION, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS MOST LIKELY
DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Device Stops Intermittently|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
POWERED-DOWN UNEXPECTEDLY WHILE USING ITS INTERNAL BATTERY. THERE WAS NO PATIENT
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE POWER DOWN
WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO
ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF 74 AND SF 101). THERE WAS NO PATIENT
RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. THE DEVICE
EVALUATION DID NOT REPLICATE THE REPORTED DEVICE FAILURE DURING PERFORMANCE
TESTING. REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF SYSTEM FAULT ERROR
MESSAGES (SF 101 AND 74) AND REVEALED THE OCCURRENCE OF A SYSTEM FAULT ERROR
MESSAGE 218. BASED ON THE INFORMATION AVAILABLE AND PREVIOUS INVESTIGATIONS OF
SIMILAR COMPLAINTS, THE INVESTIGATION DETERMINED THAT THE SYSTEM FAULT ERROR
MESSAGES WERE DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF 101 AND SF 218). THERE WAS NO PATIENT
AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS CONFIRMED
MULTIPLE OCCURRENCES OF SYSTEM FAULT SF101 INDICATING AN INCORRECT OUTLET PRESSURE
MEASUREMENT. SYSTEM FAULT SF218 ARE MAINBOARD WATCHDOG ALARMS THAT WERE TRIGGERED
FOLLOWING THE OCCURRENCE OF SF101. PERFORMANCE TESTING ON THE RETURNED DEVICE COULD
NOT REPRODUCE THE REPORTED ERRORS. INSPECTION OF THE DEVICE PNEUMATIC BLOCK
REVEALED SIGNS OF CONTAMINATION TO THE PRESSURE SENSOR DUE TO WATER INGRESS. THE
INVESTIGATION DETERMINED THAT THE REPORTED DEVICE SYSTEM FAULTS WERE DUE WATER
CONTAMINATION IN THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE DEVICE
SOFTWARE WAS UPGRADED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS
6247869||NOU|Continuous, Ventilator, Home Use|19620|ASTRAL BATTERY PACK|
RESMED THAT AN ASTRAL DEVICE DISPLAYED A "BATTERY NOT DETECTED" ERROR MESSAGE.
RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. REVIEW OF THE BATTERY LOGS
DETERMINED THAT THE REPORTED "BATTERY NOT DETECTED" ERROR MESSAGE WAS MOST LIKELY
THE RESULT OF THE DEVICE TRIGGERING THE Â¿BATTERY INOPERABLEÂ¿ ALARM. THE BATTERY
EVALUATION FOUND THAT THE BATTERY WAS DEFECTIVE. BASED ON ALL EVIDENCE, THE
INVESTIGATION DETERMINED THE BATTERY DEFECT WAS DUE TO AN ISOLATED COMPONENT
FAILURE IN THE MAIN CIRCUIT BOARD (PCB) OF THE BATTERY ASSEMBLY. THE BATTERY PACK
WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
AN ASTRAL DEVICE DISPLAYED ERROR MESSAGES (SF 65 AND SF 140). THERE WAS NO PATIENT
RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. PERFORMANCE TESTING ON THE
RETURNED DEVICE CONFIRMED THE OCCURRENCE OF SYSTEM FAULTS 65 AND 140. THE
INVESTIGATION DETERMINED THAT THE REPORTED SYSTEM FAULTS WERE DUE TO A FAILED
SOFTWARE UPGRADE PROCESS. THE SOFTWARE WAS REINSTALLED TO ADDRESS THIS ISSUE.
DURING INVESTIGATION, IT WAS REVEALED THAT THE DEVICE HAD A DEFECTIVE POWER BUTTON.
THE INVESTIGATION DETERMINED THAT THE POWER BUTTON FAILURE WAS DUE TO AN ISOLATED
COMPONENT FAILURE IN THE POWER SWITCH ASSEMBLY. RESMED'S RISK ANALYSES FOR THESE
FAILURE MODES CONCLUDE THAT THE RISKS ARE ACCEPTABLE. RESMED REFERENCE #: (B)(4).
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ERROR. THE SOFTWARE WAS UPGRADED TO
RECOGNIZING THE MAIN POWER SOURCE WHICH RESULTED IN THE INTERNAL BATTERY NOT
CHARGING. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DETERMINED THAT THE DEVICE FAILURE TO ACCURATELY DETECT THE POWER SOURCE WAS DUE TO
ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message;Power Problem|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY CHARGING FAULT. THE
INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE REPORTED
SYSTEM FAULT ERROR MESSAGE (SF 180) INDICATING AN INTERNAL BATTERY CHARGING FAULT
AND REVEALED THAT THE DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. BASED ON
ALL AVAILABLE INFORMATION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE
INVESTIGATION DETERMINED THAT THE SYSTEM FAULT ERROR MESSAGE (SF 180) WAS MOST
LIKELY DUE TO THE DEVICE USE IN A TEMPERATURE ENVIRONMENT BELOW OF ITS SPECIFIED
RANGE. THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A FAULTY
NON-RETURN VALVE (NRV) IN THE PNEUMATIC BLOCK. RESMED'S RISK ANALYSIS FOR THIS
REPORTED AS A RESULT OF THIS EVENT. (B)(4).
INTERNAL SELF-TEST WAS DUE TO A SOFTWARE ISSUE. THE SOFTWARE WAS UPGRADED TO
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO CHARGE ITS
INTERNAL BATTERY. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE,
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND AN
CHARGE WAS DUE TO A DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED
6254459||NOU|Continuous, Ventilator, Home Use|27063|ASTRAL 150 -EUR4|Malfunction|No
Display / Image|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD AN UNRESPONSIVE
DETERMINED THAT THE UNRESPONSIVE DISPLAY WAS DUE TO A DEFECTIVE LCD MODULE. THE TOP
CASE WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE
6255039||NOU|Continuous, Ventilator, Home Use|19620|BATTERIE INTERNE - ASTRAL|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL BATTERY WAS
DEFECTIVE. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS
NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN ENGINEERING
INVESTIGATION. REVIEW OF THE BATTERY LOGS AND PERFORMANCE TESTING CONFIRMED THAT
THE BATTERY WAS DEFECTIVE. BASED ON ALL EVIDENCE, THE INVESTIGATION DETERMINED THE
BATTERY DEFECT WAS DUE TO AN ISOLATED COMPONENT FAILURE IN THE MAIN CIRCUIT BOARD
(PCB) OF THE BATTERY ASSEMBLY. THE BATTERY PACK WAS REPLACED TO ADDRESS THE ISSUE.
PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF ERROR MESSAGE
(SF218), HOWEVER, IN-HOUSE TESTING COULD NOT REPRODUCE THE ERROR. FURTHER
EVALUATION OF THE DEVICE FOUND THAT THE DEVICE FAILED TO COMPLETE ITS INTERNAL
SELF-TEST. IT WAS DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-
TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO
Device Alarm System;Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE WAS CONTINUOUSLY ALARMING AND INOPERABLE. THE DEVICE WAS NOT IN USE WHEN THE
FAULT OCCURRED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE CUSTOMER CONTACTED
RESMED ASTRAL SUPPORT TO REQUEST ASSISTANCE HOW TO STOP A DEVICE WITH A BLACK
SCREEN FROM ALARMING . THE ASTRAL SUPPORT REPRESENTATIVE WENT THROUGH THE
TROUBLESHOOTING STEPS WITH THE CUSTOMER AND REQUESTED THE DEVICE TO BE REBOOTED AND
THIS RESOLVED THE ISSUE. NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. AN
EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON ALL AVAILABLE INFORMATION.
BASED ON ALL AVAILABLE EVIDENCE AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS,
IT IS POSSIBLE THAT THE REPORTED EVENT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING
INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE DEVICE FAILURE
TO COMPLETE ITS INTERNAL SELF-TEST. INVESTIGATION OF THE PHOTOS PROVIDED BY THE
SERVICE CENTER FOUND UNKNOWN SUBSTANCES DEPOSITED IN THE DEVICE. THE INVESTIGATION
DETERMINED THAT THE REPORTED ISSUE WAS DUE TO CONTAMINATION IN THE DEVICE. REVIEW
OF THE DEVICE LOGS ALSO REVEALED THE OCCURRENCE OF A SYSTEM FAULT ERROR MESSAGE (SF
74) INDICATING A SOFTWARE TASK FAULT. BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR
COMPLAINTS, IT WAS DETERMINED THAT THE SYSTEM FAULT ERROR MESSAGE (SF 74) WAS DUE
TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT
PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE OCCURRENCE OF SF188 ERROR
INDICATING A SAFETY ASSERT SYSTEM FAULT. DEVICE TESTING COULD NOT REPRODUCE THE
SF188 ERROR. ALSO DURING DEVICE EVALUATION, AN SF180 ERROR, INDICATING A BATTERY
CHARGER FAULT, WAS OBSERVED. THE SF180 ERROR COULD NOT BE REPRODUCED DURING IN-
HOUSE TESTING AND BATTERY TESTING FOUND "NO FAULT" WITH THE INTERNAL BATTERY. THE
DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE. (B)(4).
Power Problem;Inappropriate or Unexpected Reset|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE TRIGGERED A LOW BATTERY ALARM AND STOPPED VENTILATION WHILE ON A
PATIENT. THE PATIENT WAS MANUALLY VENTILATED WHILE A BACKUP VENTILATOR WAS SET UP.
THE DEVICE VENTILATION STOPPED DUE TO A DEFECTIVE BATTERY. THE BATTERY WAS REPLACED
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A FAULTY INTERNAL
BATTERY. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED, THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
INVESTIGATION. REVIEW OF THE BATTERY DATA LOGS AND PERFORMANCE TESTING CONFIRMED
THAT THE INTERNAL BATTERY WAS DEFECTIVE. BASED ON ALL EVIDENCE AND PREVIOUS
INVESTIGATIONS OF SIMILAR COMPLAINTS, THE INVESTIGATION DETERMINED THAT THE BATTERY
FAULT WAS DUE TO AN ISOLATED COMPONENT FAILURE IN THE INTERNAL BATTERY ASSEMBLY.
Charging Problem;Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS
PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO CHARGE ITS INTERNAL
BATTERY WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB WAS REPLACED
TO ADDRESS THIS ISSUE. THE EVALUATION ALSO FOUND THAT THE POWER SUPPLY HAD POOR
CONTACT WITH THE DEVICE. THE POWER SUPPLY WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
Malfunction|Inappropriate or Unexpected Reset;No Audible Alarm|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE POWERED DOWN WITHOUT AN ALARM RAISED. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE ASTRAL DEVICE WAS
RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE
DATA LOGS AND PERFORMANCE TESTING COULD NOT CONFIRM THE REPORTED VENTILATION
FAILURE WITH NO ALARM. THE DEVICE LOGS REVEALED A CIRCUIT DISCONNECTION EVENT AND
VENTILATION WAS MANUALLY STOPPED. THE EVENTS LOGS ALSO REVEALED THAT THE MUTE
BUTTON WAS ACTIVATED AFTER THE VENTILATION STOP. BASED ON THE EVIDENCE, THE
INVESTIGATION DETERMINED THAT THE DEVICE ALARM WAS PERFORMING TO SPECIFICATIONS.
DURING INVESTIGATION, THE DEVICE DISPLAYED AN ERROR MESSAGE SYSTEM FAULT 191
INDICATING THE DEVICE LOST COMMUNICATION WITH THE OUTLET FLOW SENSOR. THE
INVESTIGATION DETERMINED THAT THIS EVENT WAS DUE TO CONTAMINATION OF THE
INSPIRATORY FLOW SENSOR. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Device Displays Incorrect Message;Inappropriate or Unexpected Reset|IT WAS REPORTED
TO RESMED THAT AN ASTRAL DEVICE HAD A TOTAL POWER FAILURE ALARM EVENT. THERE WAS NO
RESMED FOR INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE OCCURRENCE
OF A POWER FAILURE ALARM. BASED ON THE INVESTIGATION AND PREVIOUS INVESTIGATIONS OF
SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE POWER FAILURE WAS DUE TO AN ISOLATED
COMPONENT FAILURE WITHIN THE BATTERY ASSEMBLY. RESMED'S RISK ANALYSIS FOR THESE
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS SWITCHING FROM
THE AC POWER SOURCE TO A DC POWER SOURCE. THE DEVICE WAS NOT IN USE WHEN THE FAULT
Failure to Calibrate;Device Displays Incorrect Message|IT WAS REPORTED TO RESMED
THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF148) AND FAILED TO COMPLETE ITS
THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND AN
EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE ERROR MESSAGE AND THE
DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WERE DUE TO A DEFECTIVE PNEUMATIC
BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THESE ISSUES. RESMED'S RISK
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND
THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.|THE DEVICE WAS RETURNED TO RESMED AND
6271976||NOU|Continuous, Ventilator, Home Use|19600|MAIN PCB - ASTRAL 150|
Malfunction|No Display / Image|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD A
DISPLAY FAILURE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE DISPLAY FAILURE WAS DUE TO A DEFECTIVE MAIN CIRCUIT
Failure to Shut Off|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO POWER
DOWN. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO
PATIENT INVOLVEMENT.|THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. THE
CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BY PERFORMING A HARD REBOOT OF THE DEVICE.
DETECTING THE MAIN POWER SUPPLY UNIT (PSU) AS AN EXTERNAL POWER SOURCE. THERE WAS
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK AND MAIN PCB. THE
PNEUMATIC BLOCK AND MAIN PCB WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK
Power Problem;Failure to Calibrate|IT WAS REPORTED TO RESMED THAT AN ASTRAL BATTERY
WILL NOT CHARGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.|
THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. BATTERY TESTING
FOUND THAT THE BATTERY WAS DEPLETED AND WILL NOT CHARGE. THE BATTERY WAS REPLACED
TO ADDRESS THIS ISSUE. THE EVALUATION ALSO FOUND THAT THE DEVICE FAILED TO COMPLETE
ITS INTERNAL SELF-TEST. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO
COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A CONTAMINATED PNEUMATIC BLOCK. THE
(4).
answer provided|Device Operational Issue|THE UNIT IS 3,5 MONTHS OLD. DURING THE
NIGHT THE VENT STOPPED DELIVERING PRESSURE AND SHUT DOWN AT APPROXIMATELY 1:56 AM,
WHILE IT WAS CONNECTED TO MAIN POWER SUPPLY. IT DIDN'T SWITCH TO INTERNAL BATTERY.
BASED ON OUR REVIEW OF THE DEVICE LOGS, THE DEVICE APPEARS TO HAVE SOUNDED AN ALARM
WHEN THE ERROR OCCURRED IN ACCORDANCE WITH THE DEVICE'S SPECIFICATIONS, BUT BREAS
MEDICAL (B)(4) IS AWAITING A RETURN OF THE DEVICE TO CONFIRM THAT THE ALARMS ARE
OPERATING PROPERLY. THE PATIENT'S MOTHER AWOKE AT APPROXIMATELY 2:00 AM TO CHECK ON
HER CHILD AND SAW THE CHILD WAS WITHOUT OXYGEN AND BECOMING BLUE AND THE VIVO WAS
NOT OPERATING. SHE IMMEDIATELY STARTED THE VENT AND HAS SAID THE UNIT WAS THEN
OPERATING FINE AND CHILD STARTED TO BREATHE AGAIN. THE DEVICE LOG INDICATES THAT
THE DEVICE WAS RESTARTED AT APPROXIMATELY 1:59 AM. THE CHILD IS PRESENTLY IN THE
HOSPITAL AND IN STABLE CONDITION, BUT WE DON'T HAVE ANY OTHER INFORMATION ABOUT THE
STATUS OF THE CHILD.|UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED
CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.
TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF138) AND SHUT DOWN
UNEXPECTEDLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. REVIEW OF THE
DEVICE LOGS CONFIRMED A SINGLE OCCURRENCE OF SYSTEM FAULT (SF138) ERROR MESSAGE
RESULTING IN A DEVICE RESET. PERFORMANCE TESTING WAS UNABLE TO REPRODUCE THE DEVICE
EVENT. BASED ON ALL EVIDENCE, THE INVESTIGATION DETERMINED THAT THE REPORTED
COMPLAINT WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE CUSTOMER WAS ISSUED
WITH A REPLACEMENT DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES
Charging Problem;Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|NO DEVICE WAS RETURNED TO RESMED FOR INVESTIGATION. BASED
ON ALL AVAILABLE INFORMATION AND INVESTIGATIONS OF SIMILAR ISSUES, THE ENGINEERING
INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS MOST LIKELY DUE TO AN ISSUE
WITH THE CHARGING MANAGEMENT CIRCUITRY OR BATTERY. (B)(4).
Alarm Not Visible;No Audible Alarm|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
WAS ACCIDENTLY UNPLUGGED AND IT SHUT DOWN WITHOUT AN ALARM. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE
TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE
HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED
Device Inoperable;Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED A RED SCREEN AND A BATTERY FAILURE ERROR MESSAGE . THERE WAS NO PATIENT
AN EVALUATION WAS PERFORMED. THE EVALUATION COULD NOT CONFIRM THE REPORTED
COMPLAINT AND IN-HOUSE TESTING WAS NOT ABLE TO REPRODUCE THE DEVICE FAILURE. THE
DEVICE EVALUATION RESULTED IN "NO FAULT FOUND." REVIEW OF THE DEVICE LOGS SHOWED
THAT THE DEVICE WAS DUE TO A 2 YEAR PREVENTIVE MAINTENANCE. BATTERY TESTING FOUND
NO ISSUES WITH THE BATTERY. THE BATTERY WAS REPLACED AS PART OF PREVENTIVE
MAINTENANCE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED REFERENCE
#: (B)(4).
TIME. (B)(4).
Device Displays Incorrect Message;Device Stops Intermittently|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE INCREASED PRESSURE, ALARMED AND SUBSEQUENTLY SHUT
DOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
IS CURRENTLY BEING RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION.
RESMED REFERENCE #: (B)(64
AN ASTRAL DEVICE DISPLAYED A SYSTEM FAULT MESSAGE (SF 133) INDICATING A POSSIBLE
PRESSURE MEASUREMENT ISSUE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
(B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE SYSTEM
FAULT 133 WAS A SINGLE OCCURRENCE AND COULD NOT BE REPRODUCED DURING IN-HOUSE
RESMED THAT AN ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY INOPERABLE ERROR
MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|A
PRELIMINARY REVIEW OF THE DEVICE LOGS SHOWED THE OCCURRENCE OF ERROR MESSAGE SF180
INDICATING A BATTERY CHARGER FAULT AND BATTERY COMMUNICATION LOST ALARMS. THE
(4).
Event Without Identified Device or Use Problem|IT WAS REPORTED TO RESMED THAT A
PEDIATRIC TRACH PATIENT WAS USING AN ASTRAL DEVICE WHEN THE DEVICE ALARMED ALERTING
THE CAREGIVER OF AN ISSUE WITH THE PATIENT. PER THE REPORTER, THE DEVICE ALARMED
DUE TO A BLOCKAGE IN THE PATIENTS AIRWAY (MUCUS BUILD UP). THE CAREGIVER ATTEMPTED
TO REMOVE THE MUCUS BUILD UP VIA SUCTIONING AND TRACH CHANGE BUT WAS NOT SUCCESSFUL
AND THE PATIENT EXPIRED. IT WAS REPORTED THAT THE PATIENT HAD A DO NOT RESUSCITATE
ORDER (DNR) THEREFORE NO AMBU BAGGING OR CPR WAS PROVIDED.|THERE WAS NO REPORT OF A
DEVICE MALFUNCTION RELATING TO THIS EVENT. THE DEVICE WAS RETURNED RESMED FOR AN
INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE NON-RETURN VALVE (NRV). THE CUSTOMER WAS
ISSUED WITH A REPLACEMENT DEVICE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE
DETECTING THE MAIN POWER SOURCE AS AN EXTERNAL BATTERY. THERE WAS NO PATIENT INJURY
EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS FOUND NO EVENTS OF A POWER
FAILURE. THE EVALUATION SHOWED THAT AN ASTRAL DEVICE WAS DETECTING AN EXTERNAL
POWER SOURCE WHEN IT WAS CONNECTED TO THE MAIN POWER. IT WAS DETERMINED THAT THE
REPORTED DEVICE ISSUE WAS DUE TO A DEFECTIVE MAIN CIRCUIT BOARD (PCB). THE MAIN PCB
WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE EVALUATION ALSO REVEALED WATER
CONTAMINATION IN THE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
THE ISSUE. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS
Device Stops Intermittently|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE IS
SHUTTING OFF. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.|THE
ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. PERFORMANCE
TESTING COULD NOT REPRODUCE THE REPORTED EVENT AND THE DEVICE OPERATED ACCORDING TO
SPECIFICATIONS. THE EVALUATION RESULTED IN "NO FAULT FOUND" WITH THE DEVICE. THE
DEVICE WAS SERVICED, TESTED, CALIBRATED, AND CLEANED BEFORE IT WAS RETURNED TO THE
CUSTOMER. (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS DETECTING THE
MAIN POWER SUPPLY (PSU) AS AN EXTERNAL BATTERY AND FAILED TO CHARGE ITS INTERNAL
DETERMINED THAT THE DEVICE FAILURE TO ACCURATELY DETECT THE POWER SOURCE WAS DUE TO
ISSUE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS
RESMED THAT AN ASTRAL DEVICE POWERED DOWN WHILE VENTILATING A PATIENT AND DISPLAYED
ERROR MESSAGES (SF101 AND SF218). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
REPLACED TO ADDRESS THIS ISSUE. DURING DEVICE EVALUATION IT WAS FOUND THAT THE LCD
MODULE WAS INOPERABLE. THE LCD MODULE WAS REPLACED TO ADDRESS THIS ISSUE. THE
DEVICE WAS SERVICED, CALIBRATED, TESTED AND CLEANED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE RESMED REFERENCE #: (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY UNIT (PSU) WAS
DEVICE AND THE POWER SUPPLY UNIT (PSU) WERE RETURNED TO RESMED AND AN EVALUATION
WAS PERFORMED. THE EVALUATION FOUND THAT THE PSU FAILED TO CHARGE THE INTERNAL
BATTERY. IT WAS CONFIRMED THAT THE PSU WAS DEFECTIVE. THE PSU WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND RETUNED TO THE CUSTOMER. RESMED'S
HAVING BATTERY AND POWER ISSUES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
PERFORMED. THE EVALUATION CONFIRMED THAT THE ASTRAL DEVICE DISPLAYED AN INTERNAL
BATTERY DEGRADED ALARM AND DETERMINED THAT THE POWER ISSUE WAS DUE TO A DEFECTIVE
BATTERY. THE BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED,
DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED A SINGLE
OCCURRENCE OF SYSTEM FAULT 74. PERFORMANCE TESTING COULD NOT REPRODUCE THE DEVICE
ERROR. THE EVALUATION DETERMINED THAT THE ISSUE WAS POSSIBLY DUE TO A SOFTWARE
ISSUE. THE SOFTWARE WAS UPGRADED, THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO DETECT AN
AC POWER SOURCE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE DEVICE FAILURE TO DETECT THE POWER SOURCE WAS DUE TO
ACCEPTABLE. (B)(4).
Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE WAS ALARMING AND
RESMED REFERENCE #: B)(4).
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO
RECOGNIZE A MAIN AC POWER SUPPLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN
Malfunction|Device Displays Incorrect Message|THE PATIENT WAS VENTILATED AT (B)(6)
WITH A VIVO 60 FOR APPROXIMATELY 24 HOURS. ON (B)(6) 2017, THE DEVICE (SN (B)(4))
SHOWED AN ALARM OF "HUMIDITY COMPENSATION LOST". THE RESPONDING STAFF CHANGED THE
DOUBLE LIMB CIRCUIT, WHICH SEEMED TO RESOLVE THE ISSUE. DURING THE NIGHT, THE SAME
ALARM APPEARED AND THE BATTERY SYMBOL WAS OBSERVED BLINKING DESPITE THAT THE DEVICE
WAS OPERATED ON MAINS ELECTRICITY. THE PATIENT WAS ADAPTED TO ANOTHER VIVO 60 (SN
(B)(4)) AND THE VTE AND MV LOW ALARMS APPEARED SHORTLY THEREAFTER. THE PATIENT WAS
RE-ADAPTED TO THE FIRST DEVICE (SN (B)(4)) WITH THE CHANGED CIRCUIT. THE A.M.
PROBLEMS OCCURRED, FOLLOWED BY A BLACK-OUT. THE PATIENT WAS TRANSPORTED TO A NEARBY
HOSPITAL. AFTER CONSULTING A MEDICAL TECHNICIAN AND A MEDICAL DIRECTOR, THE (B)(6)
DISCUSSED THIS SITUATION AND CONSULTED THE MANUFACTURER. THE DIFFERENT ALARMS ON
BOTH THE DEVICES AND THE SUBSEQUENT BLACK-OUT COULD NEITHER BE EXPLAINED NOR
DUPLICATED UNDER THE LABORATORY CONDITIONS. BECAUSE OF LACK OF AN EXPLANATION AND
THE QUICK SUCCESSION OF DIFFERENT ALARMS ON THESE DEVICES, IT WAS RECOMMENDED THAT
THE MANUFACTURER INVESTIGATE THESE INCIDENTS AND PERFORM ADDITIONAL TESTS. THE
FIRST REPORT WAS CREATED BY THE VENTILATION CENTER AND THE RESULT OF THE TEST FROM
(B)(6) CAN BE PROVIDED VIA E-MAIL UPON REQUEST. BASED ON THE INFORMATION PROVIDED
AT THIS TIME, INCLUDING INVESTIGATION RESULTS INDICATING A USE ERROR, THE REPORTED
EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|UNDER EUROPEAN LAW, PATIENT
FDA SINCE THE VIVO 50 IN THE US IS SIMILAR MODEL. THEREFORE, THE VIVO 50 PRODUCT
CODE NOU, THE VIVO 50 510(K)#K123144, AND THE VIVO 50 (B)(4) HAVE BEEN USED IN THIS
REPORT.
Malfunction|Device Displays Incorrect Message|THE PATIENT WAS VENTILATED AT (B)(6)
THERAPEUTICS (B)(4) WITH A VIVO 60 FOR APPROXIMATELY 24 HOURS. ON (B)(6) 2017, THE
DEVICE (SN (B)(4)) SHOWED AN ALARM OF "HUMIDITY COMPENSATION LOST". THE RESPONDING
STAFF CHANGED THE DOUBLE LIMB CIRCUIT, WHICH SEEMED TO RESOLVE THE ISSUE. DURING
THE NIGHT, THE SAME ALARM APPEARED AND THE BATTERY SYMBOL WAS OBSERVED BLINKING
DESPITE THAT THE DEVICE WAS OPERATED ON MAINS ELECTRICITY. THE PATIENT WAS ADAPTED
TO ANOTHER VIVO 60 (SN (B)(4)) AND THE VTE AND MV LOW ALARMS APPEARED SHORTLY
THEREAFTER. THE PATIENT WAS RE-ADAPTED TO THE FIRST DEVICE (SN (B)(4)) WITH THE
CHANGED CIRCUIT. THE A.M. PROBLEMS OCCURRED, FOLLOWED BY A BLACK-OUT. THE PATIENT
WAS TRANSPORTED TO A NEARBY HOSPITAL. AFTER CONSULTING A MEDICAL TECHNICIAN AND A
MEDICAL DIRECTOR, THE (B)(6) THERAPEUTICS DISCUSSED THIS SITUATION AND CONSULTED
THE MANUFACTURER. THE DIFFERENT ALARMS ON BOTH THE DEVICES AND THE SUBSEQUENT
BLACK-OUT COULD NEITHER BE EXPLAINED NOR DUPLICATED UNDER THE LABORATORY
CONDITIONS. BECAUSE OF LACK OF AN EXPLANATION AND THE QUICK SUCCESSION OF DIFFERENT
ALARMS ON THESE DEVICES, IT WAS RECOMMENDED THAT THE MANUFACTURER INVESTIGATE THESE
INCIDENTS AND PERFORM ADDITIONAL TESTS. THE FIRST REPORT WAS CREATED BY THE (B)(6)
CENTER AND THE RESULT OF THE TEST FROM (B)(6) CAN BE PROVIDED VIA E-MAIL UPON
REQUEST. BASED ON THE INFORMATION PROVIDED AT THIS TIME, INCLUDING INVESTIGATION
RESULTS INDICATING A USE ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21
CFR PART 803.3.|UNDER (B)(6) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL
AND WILL NOT BE RELEASED BY THE HOSPITAL. THE VIVO 60 IS NOT MARKETED IN THE USA,
BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS
SIMILAR MODEL. THEREFORE, THE VIVO 50 PRODUCT CODE NOU, THE VIVO 50 510(K)#K123144,
AND THE VIVO 50 UDI # (B)(4) HAVE BEEN USED IN THIS REPORT.
CONFIRMED THE REPORTED ISSUE AND PERFORMANCE TESTING REPRODUCED THE DEVICE FAILURE.
THE INVESTIGATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-
TEST WAS DUE TO A DEFECTIVE NON-RETURN VALVE (NRV) IN THE PNEUMATIC BLOCK. RESMED'S
Malfunction|Device Operates Differently Than Expected|WHILE MR. (B)(46, TECHNICIAN
WAS PERFORMING MAINTENANCE HE NOTICED THAT SOFTWARE UPDATE WAS OVERDUE. AFTER HE
UPDATED THE SOFTWARE PATIENT WAS ADAPTED TO THE VENTILATOR. WHILE THE TECHNICIAN
WAS PERFORMING MAINTENANCE ON THE SECOND DEVICE, PATIENT HAD SOME ISSUES WITH THE
DEVICE HE HAD JUST PERFORMED THE MAINTENANCE. THE DEVICE DOUBLED EVERY THIRD
BREATH. SINCE BOTH MACHINES WERE UPDATED AT THE SAME TIME, PATIENT WAS ADAPTED TO
HIS FORMER VENTILATOR (LVT 1000). ON THE SAME DAY THE TECHNICIAN BROUGHT 2 NEW
VENTILATORS FROM HIS HEAD OFFICE. TECHNICIAN BROUGHT BOTH DEVICES BACK TO HIS
OFFICE TO FIND THE CAUSE OF PROBLEM. AFTER ANALYZING THE DATA, THE MR. (B)(6),
TECHNICIAN INFORMED BREAS THAT THE PROBLEM WAS CAUSED BY THE NEW UPDATE, BECAUSE
THE PARAMETERS FOR TRIGGER WERE EITHER SET LOWER OR ERASED. BASED ON THE
INFORMATION PROVIDED AT THIS TIME, INCLUDING INVESTIGATION RESULTS INDICATING A USE
ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|UNDER
RELEASED BY THE HOSPITAL. THIS REPORT IS SUBMITTED TO FDA AFTER USER REPORT HAS
BEEN FILED IN (B)(4). NEW MORE SENSITIVE FIRMWARE UPLOADED.
Malfunction|Device Operates Differently Than Expected|WHILE MR. (B)(4), TECHNICIAN
WAS PERFORMING MAINTENANCE, HE NOTICED THAT SOFTWARE UPDATE WAS OVERDUE. AFTER HE
UPDATED, THE SOFTWARE PATIENT WAS ADAPTED TO THE VENTILATOR. WHILE THE TECHNICIAN
WAS PERFORMING MAINTENANCE ON THE SECOND DEVICE, PATIENT HAD SOME ISSUES WITH THE
DEVICE HE HAD JUST PERFORMED THE MAINTENANCE. THE DEVICE DOUBLED EVERY THIRD
BREATH. SINCE BOTH MACHINES WERE UPDATED AT THE SAME TIME, PATIENT WAS ADAPTED TO
HIS FORMER VENTILATOR (LVT 1000). ON THE SAME DAY, THE TECHNICIAN BROUGHT 2 NEW
VENTILATORS FROM HIS HEAD OFFICE. TECHNICIAN BROUGHT BOTH DEVICES BACK TO HIS
OFFICE TO FIND THE CAUSE OF PROBLEM. AFTER ANALYZING THE DATA, MR. (B)(4),
TECHNICIAN INFORMED BREAS THAT THE PROBLEM WAS CAUSED BY THE NEW UPDATE, BECAUSE
THE PARAMETERS FOR TRIGGER WERE EITHER SET LOWER OR ERASED. BASED ON THE
INFORMATION PROVIDED AT THIS TIME, INCLUDING INVESTIGATION RESULTS INDICATING A USE
ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|UNDER
RELEASED BY THE HOSPITAL. THIS REPORT IS SUBMITTED TO FDA AFTER USER REPORT HAS
BEEN FILED IN (B)(6). NEW MORE SENSITIVE FIRMWARE UPLOADED.
Malfunction|Power Problem|IT WAS REPORTED THAT AN ASTRAL DEVICE FAILED TO DETECT AN
EXTERNAL POWER SUPPLY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION DETERMINED THAT THE DEVICE FAILURE TO DETECT THE POWER SOURCE WAS DUE TO
ACCEPTABLE. (B)(4).
Malfunction|Device Displays Incorrect Message|AT 03:00 AM THE PATIENTS WIFE
PERFORMED A SUCTION. THE VIVO 50 IN QUESTION STARTED ALARMING FOR HIGH PRESSURE/LOW
TIDAL VOLUME AND THEN STOPPED WORKING AND TURNED OFF. THE DEVICE WAS NOT ABLE TO BE
SWITCH ON, SO SHE PICKED UP A RESUSCITATOR AND VENTILATED THE PATIENT THE NEXT 3
HOURS UNTIL THE REPLACEMENT WAS INSTALLED. PATIENT SURVIVED.|UNDER EUROPEAN LAW,
HOSPITAL.
Malfunction|Device Operates Differently Than Expected|ACCORDING TO CUSTOMER DEVICE
WAS IN HOME MODE WHEN DEVICE SETTINGS WAS CHANGED DURING ACTIVE TREATMENT. SEVEN
ALARMS DEACTIVATED PLUS PEEP PRESSURE SET FROM 7 TO 0 MBR. TIME PERIOD: (B)(6)
2017. BASED ON THE INFORMATION PROVIDED AT THIS TIME, INCLUDING INVESTIGATION
RESULTS INDICATING A USER ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21
CFR PART 803.3. NOTE: "DEVICE MODE: THE TWO DEVICE MODES OF THE VIVO 50 ARE USED
FOR CONTROLLING THE USER ACCESS TO THE VENTILATOR SETTINGS. CLINICAL MODE ALLOWS
FULL ACCESS TO THE VIVO 50 TREATMENT PARAMETERS FOR HEALTH CARE PROFESSIONALS. HOME
MODE IS USED FOR REGULATING THE ACCESS TO THE VENTILATOR'S SETTINGS FOR PATIENTS
AND LAY PERSONS."|UNDER (B)(6) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL
AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS REPORT IS SUBMITTED TO FDA AFTER
ADDITIONAL INFORMATION WAS RECIEVED. PATIENT LOG FILE EVALUATED.
Malfunction|Charging Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED
TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING
6670161||NOU|Continuous, Ventilator, Home Use|27943|OBSOLETE PSU - ASTRAL|
DEFECTIVE POWER SUPPLY UNIT (PSU). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE ASTRAL DEVICE AND THE POWER SUPPLY UNIT WERE RETURNED TO
RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE POWER
SUPPLY UNIT (PSU) WAS DEFECTIVE. THE PSU WAS REPLACED TO ADDRESS THIS ISSUE.
ACCEPTABLE. (B)(4).
DISPLAYED AN ERROR MESSAGE (SF65) INDICATING CORRUPTED PROGRAM DATA. THERE WAS NO
RESMED AND AN EVALUATION WAS PERFORMED. THE REPORTED FAILURE COULD NOT BE
REPRODUCED DURING IN-HOUSE TESTING AND THE DEVICE OPERATED PER SPECIFICATIONS. THE
DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE. (B)(4).
Power Problem;Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED A SYSTEM FAULT ERROR MESSAGE (SF 180) INDICATING A BATTERY
CHARGER FAULT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE
EVALUATION DETERMINED THAT THE REPORTED EVENT WAS DUE TO A BATTERY ISSUE. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. RESMED'S RISK ANALYSIS FOR THIS
Battery Problem;Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY DEGRADED ALARM. THERE WAS NO PATIENT
AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE ALARM WAS DUE TO A
DEFECTIVE INTERNAL BATTERY. THE INTERNAL BATTERY WAS REPLACED TO RESOLVE THE ISSUE.
(B)(4).
RESMED THAT AN ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY FAULT. THERE WAS NO
PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY A
THIRD PARTY SERVICE CENTER AND AN EVALUATION WAS PERFORMED. THE REPORTED FAILURE
COULD NOT BE CONFIRMED OR REPRODUCED DURING EVALUATION AND THE DEVICE OPERATED PER
SPECIFICATIONS. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT
WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES
Malfunction|Device Displays Incorrect Message|ON (B)(6) 2017, BREAS MEDICAL
RECEIVED INFORMATION THAT VIVO 50 S/N (B)(4) HAD BEEN INVOLVED IN AN INCIDENT IN
(B)(6). FAULT DESCRIPTION PER THE REPORTER "THE DEVICE HAS FAILED DURING MOBILE
OPERATION OF THE VENTILATION DEVICE (BATTERY OPERATION). THE ERROR CODE "ERROR 16"
WAS DISPLAYED ON THE DISPLAY. THE RESPIRATOR COULD BE OPENED ONLY AFTER APPROX. 2
MIN TURN BACK ON. THE PATIENT HAD TO BE VENTILATED MANUALLY. THE DEVICE IS SENT TO
THE MANUFACTURER FOR ANALYSIS." THE PATIENT INVOLVED WAS NOT INJURED DURING THE
INCIDENT.|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND
WILL NOT BE RELEASED BY THE HOSPITAL. (B)(4).
6716367||NOU|Continuous, Ventilator, Home Use|27053|ASTRAL 150 - DEU|Malfunction|No
Display / Image|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A PARTIALLY
INOPERABLE TOUCH SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
EVALUATION CONFIRMED THE TOUCH SCREEN WAS PARTIALLY INOPERABLE DUE TO A DEFECTIVE
LCD MODULE. THE LCD MODULE WAS REPLACED TO RESOLVE THE ISSUE. RESMED'S RISK
Malfunction|Device Displays Incorrect Message|THE PATIENT WAS VENTILATED WITH A
VIVO 60. ON (B)(6) 2017, THE DEVICE STOPPED WITHOUT WARNING AND ALARM WHILE THE
USER WAS TRANSPORTED TO THE HOSPITAL. THE DEVICE WAS ABLE TO RESTART BUT AFTER A
SHORT WHILE IT STOPPED AGAIN. BASED ON THE INFORMATION PROVIDED AT THIS TIME,
INCLUDING INVESTIGATION RESULTS INDICATING A USE ERROR, THE REPORTED EVENT IS
CONSIDERED REPORTABLE PER 21 CFR PART 803.3.|UNDER EUROPEAN LAW, PATIENT
FDA SINCE THE VIVO 50 IN THE US IS SIMILAR MODEL. THEREFORE, THE VIVO 50 PRODUCT
CODE NOU, THE VIVO 50 510(K)#K123144, AND THE VIVO 50 UDI #732182215005 HAVE BEEN
USED IN THIS REPORT.
6852073|20170614|NOU|Continuous, Ventilator, Home Use|VIVO 50|BREAS VIVO 50|Death|
Device Displays Incorrect Message|ON AUGUST 10TH, 2017, BREAS MEDICAL RECEIVED
INFORMATION THAT VIVO 50 S/N (B)(4) HAD BEEN INVOLVED IN AN INCIDENT IN (B)(6).
FAULT DESCRIPTION PER THE REPORTER "A BEDRIDDEN PATIENT VENTILATED TO VIVO 50
DURING THE NIGHT, THE VENTILATION SUDDENLY STOPPED FOLLOWING THE ERROR DISPLAY 39
CORRESPONDING TO A DEFECT ON THE TURBINE. ERROR OCCURRED AT 22:52, PATIENT DIED AT
00:45."|UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL
NOT BE RELEASED BY THE HOSPITAL. INVESTIGATION: THE DEVICE WAS SENT TO BREAS
MEDICAL (B)(4) AND ARRIVED (B)(6) 2017. ON (B)(6), BREAS MEDICAL AB STARTED THE
EXAMINATION OF THE DEVICE. GENERAL INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE
IS IN GOOD SHAPE, BUT THE CLICK-ON CONNECTION COVER WAS MISSING. THE DEVICE
LOGFILES WERE INVESTIGATED AND THEY SHOW A LOW PRESSURE ALARM WHICH IS A
PHYSIOLOGICAL ALARM AND THAT WAS FOLLOWED BY AN INTERNAL FUNCTION FAILURE. THE
DEVICE WAS STARTED AND IT DID NOT SOUND LIKE IT SHOULD AND FUNCTION FAILURE ERROR
39 TURNED UP, AND THE DEVICE WAS NOT ABLE TO START VENTILATION. DUE TO THE STRANGE
NOISE FROM THE DEVICE IT WAS DECIDED TO INVESTIGATE THE TURBINE. THE TURBINE WAS
OPENED AND IT WAS OBVIOUS THAT IT HAS BEEN EXPOSED TO LIQUID. THE ORIGINAL TURBINE
FROM THE RETURNED UNIT WAS EXCHANGED FOR FAULT TRACING. AFTER THE TURBINE HAD BEEN
CHANGED THE DEVICE WAS ASSEMBLED AGAIN AND TURNED ON. THE DEVICE STARTED CORRECTLY,
WITHOUT ANY STRANGE SOUND AND WITHOUT ERROR 39. LIQUID INGRESS WAS ALSO PRESENT ON
THE INSIDE OF THE DISPLAY, THE CPU-BOARD AND THE PSU-BOARD. CAUSE: FAULT TRACING OF
THE DEVICE COULD ESTABLISH THAT THE ERROR 39 WAS DUE TO THAT LIQUID, DUE TO USE
ERROR, HAVE ENTERED THE TURBINE AND DAMAGE IT. CONCLUSION AND ACTIONS BREAS DO NOT
AT THIS MOMENT SEE ANY INCREASING FAILURE TREND OF WATER INGRESS IN THE BLOWER OF
THE VIVO 50 MODEL VENTILATOR. THE VIVO 50 MODEL VENTILATOR IS NOT WATER RESISTANT
AND HAS THE FOLLOWING WARNINGS ABOUT THIS IN THE INSTRUCTIONS FOR USE (OPERATOR
MANUAL VIVO50 005003 ENEU C-3): BULLET UNDER 2.1 GENERAL USER PRECAUTIONS: "THE
VIVO 50 MAY NOT WORK PROPERLY IF ANY PART HAS BEEN DROPPED, DAMAGED OR SUBMERGED IN
WATER." BULLET UNDER 2.3 ENVIRONMENTAL CONDITIONS: "DO NOT EXPOSE THE VIVO 50 TO
RAIN OR SNOWFALL." ALSO THE FIRST BULLET UNDER SECTION 2.1 GENERAL USER
PRECAUTIONS: "WHEN A PATIENT IS TREATED, THERE MUST BE A SUPERVISING PERSON PRESENT
DURING THE TREATMENT IN ORDER TO TAKE CARE OF ALARMS AND CONDITIONS THAT THE
PATIENT CANNOT SOLVE ON THEIR OWN." THE INFORMATION BREAS MEDICAL HAVE RECEIVED
ABOUT IF A CARE-GIVER OR QUALIFIED ATTENDANT PRESENT IS: "AS I UNDERSTOOD, WHEN THE
INCIDENT OCCURRED, THE PATIENT WAS ALONE, I DON'T KNOW HOW EMERGENCY STAFF WAS
CALLED. IT SEEMS THAT PATIENT HAD AN EMERGENCY CALL LOCKET" - INFORMATION RECEIVED
FROM THE DISTRIBUTOR. IT SEEMS LIKE THE WARNINGS IN THE SAFETY SECTIONS IN THE
INSTRUCTIONS FOR USE HAVE NOT BEEN FOLLOWED. THE DEVICE HAS PERFORMED AS DESIGNED
AND INTENDED IF AN INTERNAL FUNCTIONAL FAILURE OCCURS, BY TRIGGERING A FAIL-SAFE
SHUT-DOWN AND GIVING A HIGH PRIORITY AUDIBLE AND VISUAL ALARM. RISK MITIGATIONS
CURRENTLY IN PLACE ARE THEREFORE CONSIDERED EFFECTIVE TO MAINTAIN THE FINAL RISK
LEVEL AT TECHNICAL ALARP (AS LOW AS REASONABLY PRACTICAL) WITHOUT TAKEN ANY
ECONOMIC ASPECTS INTO CONSIDERATIONS. BASED ON THE INFORMATION PROVIDED, CONFIRMING
EXISTING MITIGATIONS ARE FOUND EFFECTIVE. WE WILL CONTINUE TO TRACK AND TREND THE
ISSUE ACCORDING TO THE PROCEDURES OF OUR QUALITY MANAGEMENT SYSTEM. NO FURTHER
ACTIONS ARE PLANNED AT THIS TIME. THIS INCIDENT HAS ADDITIONALLY BEEN REPORTED TO
THE (B)(6), IN MANUFACTURER'S VIGILANCE REPORT TO (B)(6).
Malfunction|Device Operates Differently Than Expected|ON JUNE 10TH, 2017, BREAS
MEDICAL RECEIVED INFORMATION THAT VIVO 50 S/N (B)(4) HAD BEEN INVOLVED IN AN
INCIDENT IN (B)(6). FAULT DESCRIPTION PER THE REPORTER "THE MOTHER PUTS HER SON
UNDER VENTILATION AFTER HAVING SWITCHED ON THE DEVICE AT 10:57 AND FINDS THE
PATIENT STILL CONNECTED TO THE VIVO 50 BUT DEVICE SWITCHED OFF AT 11:55; SHE TELLS
US NOT TO HAVE HEARD ANY ALARM. EXTRACTION OF THE DATA SHOWS THE START-UP OF THE
DEVICE BUT THIS IS FOLLOWED BY AN UNEXPECTED STANDBY OF ABOUT 20 MINUTES ABOUT 40
MINUTES LATER. NOTE THAT THE PATIENT HAS ABSOLUTELY NO POSSIBILITY TO ACT ALONE ON
HIS DEVICE. THIS PATIENT IS TRACHEOTOMIZED AND DEPENDENT ON HIS VENTILATION (24H /
24)". THE PATIENT WAS NOT INJURY DURING THE INCIDENT.|UNDER EUROPEAN LAW, PATIENT
INVESTIGATION: THE DEVICE WAS SENT TO BREAS MEDICAL (B)(4) AND ARRIVED 25TH OF
AUGUST 2017. ON JULY 28, BREAS MEDICAL AB STARTED THE EXAMINATION OF THE DEVICE. Â·
GENERAL INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE IS IN GOOD SHAPE Â· THE
DEVICE ALARM WAS CHECKED AND SOUNDED AS IT SHOULD. Â· THE DEVICE HAS FIRMWARE
VERSION 2.07 INSTALLED. Â· TO PUT IT INTO STAND-BY TWO STEPS ARE REQUIRED. THE LOG
FILES WERE DOWNLOADED AND REVIEWED WITH THE PC SOFTWARE VERSION 3.2.3.2. THE DEVICE
WAS ACTIVATED 10:57:06 (B)(6) 2017, FOLLOWED BY A LOW PRESSURE AND DISCONNECTION
ALARM THAT LASTED ABOUT 20S BEFORE THEY WERE ATTENDED. THERE ARE NO UNUSUAL ENTRIES
IN THE LOG FILE, SUCH AS ALARMS, POWER MESSAGES, INTERNAL MESSAGES AROUND THAT TIME
OF THE STAND-BY. THE DEVICE IS PUT INTO STAND-BY MODE 11:37:06 (B)(6) 2017 AND
ACTIVATED AGAIN 11:55:07 (B)(6) 2017. CAUSE: FAULT TRACING OF THE DEVICE COULD NOT
ESTABLISH ANY HARDWARE OR SOFTWARE FAILURE ON THE DEVICE. LOGFILE HAS BEEN REVIEWED
AND THE CONCLUSION IS THAT THERE IS NO INDICATION THAT THE DEVICE HAS SET ITSELF
INTO STAND-BY. CONCLUSION AND ACTIONS: BREAS DO NOT AT THIS MOMENT SEE ANY
INCREASING FAILURE TREND FOR USE ERROR OF THE VIVO 50 MODEL VENTILATORS. NO FAILURE
OF THE DEVICE CAN BE ESTABLISHED. THERE HAS BEEN NO PERMANENT PATIENT HARM REPORTED
AS A RESULT OF THE INCIDENT. RISK MITIGATIONS CURRENTLY IN PLACE ARE THEREFORE
CONSIDERED EFFECTIVE TO MAINTAIN THE FINAL RISK LEVEL AT TECHNICAL ALARP (AS LOW AS
REASONABLY PRACTICAL) WITHOUT TAKEN ANY ECONOMIC ASPECTS INTO CONSIDERATIONS. BASED
ON THE INFORMATION PROVIDED, CONFIRMING EXISTING MITIGATIONS ARE FOUND EFFECTIVE.
THE REPORT CONFIRMS THAT ANY PATIENT INVOLVED DID NOT SUFFER ANY SERIOUS INJURY. WE
WILL CONTINUE TO TRACK AND TREND THE ISSUE ACCORDING TO THE PROCEDURES OF OUR
QUALITY MANAGEMENT SYSTEM. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. THIS
INCIDENT HAS ADDITIONALLY BEEN REPORTED TO THE (B)(6).
Power Problem;Device Displays Incorrect Message|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED A DEPLETED BATTERY ALARM WHILE THE BATTERY WAS FULLY
CHARGED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED
UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
No Display / Image;Device Inoperable|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE HAD AN UNRESPONSIVE TOUCH SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE CUSTOMER CONTACTED RESMED TO REQUEST ASSISTANCE
TROUBLESHOOTING AN ASTRAL DEVICE WITH AN UNRESPONSIVE TOUCH SCREEN AND CANNOT BE
POWERED DOWN. AN ASTRAL SUPPORT REPRESENTATIVE WENT THROUGH THE TROUBLESHOOTING
STEPS WITH THE CUSTOMER AND REQUESTED THAT THE DEVICE WAS REBOOTED. REBOOTING
RESOLVED THE CUSTOMER ISSUE. RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED FOR
EVALUATION. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO
CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4). NOTE:
DURING THE REVIEW OF THE COMPLAINT RECORD, IT WAS NOTED THAT THE DATE OF AWARENESS
WAS INCORRECTLY ENTERED RESULTING IN THE DELAY OF SUBMISSION.
Device Displays Incorrect Message;Battery Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY INOPERABLE ALARM. THE DEVICE WAS NOT IN
DETERMINED THAT THE BATTERY INOPERABLE ALARM WAS DUE TO A DEFECTIVE INTERNAL
Malfunction|Device Operates Differently Than Expected|THE PATIENT WAS WITH HIS WIFE
IN THE GARDEN WHEN THE WIFE SUDDENLY OBSERVED THAT HER HUSBAND WAS RESTLESS AND
BLUISH (CYANOTIC) IN THE FACE. SHE THEN CHECKED THE VENTILATOR AND FOUND THAT IT
HAD SWITCHED OFF INDEPENDENTLY. SHE COULD JUST CONNECT HER HUSBAND TO THE
REPLACEMENT UNIT TO AVOID FURTHER COMPLICATIONS. THE PATIENT WAS SUBSEQUENTLY
STABLE, ONLY A RUPTURED VESSEL IN THE EYE WAS FOUND.|UNDER EUROPEAN LAW, PATIENT
(B)(6). INVESTIGATION THE DEVICE WAS SENT TO BREAS MEDICAL (B)(4) AND ARRIVED 21TH
OF SEPTEMBER 2017. ON SEPTEMBER 25 TO 27, BREAS MEDICAL (B)(4) STARTED THE
EXAMINATION OF THE DEVICE. GENERAL INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE
IS IN GOOD SHAPE. THE DEVICE ALARM WAS CHECKED AND SOUNDED AS IT SHOULD, THE DEVICE
HAD ALARM VOLUME SET ON VOLUME 5 OUT OF 9. THE DEVICE HAS FIRMWARE VERSION 2.12
INSTALLED. THE DEVICE IS MISSING THE PATIENT AIR INLET FILTER AND THE COOLING FAN
AIR INLET IS DUSTY. THE LOG FILES WERE DOWNLOADED AND REVIEWED WITH THE PC SOFTWARE
VERSION 3.2.3.2. THE DEVICE HAS 3 SESSIONS REGISTERED: Â· 2017-08-28, STARTING AT
08:38:50 WAS ENDED AT 08:39:03, Â· 2017-08-28, STARTING AT 13:09:55 WAS ENDED AT
14:04:23, Â· 2017-08-28, STARTING AT 14:07:03 WAS ENDED AT 14:08:10. WE HAVE NOT
RECEIVED INFORMATION OF WHICH TREATMENT SESSION THE INCIDENT OCCURRED UNDER. THE
FIRST AND LAST SESSION IS ABOUT 1MIN EACH, SO THE ASSUMPTION IS THAT THE INCIDENT
HAPPENED UNDER THE SECOND SESSION. THE SESSION HAS 4 ALARMS IN THE BEGINNING (LOW
PRESSURE, HIGH TIDAL VOLUME, HIGH MINUTE VOLUME AND DISCONNECTION). THESE ALARMS
ENDED AFTER 3 SECONDS AND ARE RELATED TO THE MASK NOT BEING ON THE PATIENT AT
START-UP WHICH IS ACCORDING TO THE MANUAL. AFTER ABOUT 1 HOUR AFTER TREATMENT
STARTED, AT 14:03:51, THE FOUR ALARMS APPEAR AGAIN AND AT 14:04:23 THE DEVICE IS
PUT INTO STAND-BY THESE ALARMS ARE NOT FUNCTION FAILURE ALARMS THAT WILL TERMINATE
THE TREATMENT. THE ENTRIES IN THE LOGFILES INDICATES THAT THE DEVICE IS SET IN TO
STANDBY IN A NORMAL WAY. THE LOGS SHOW THAT A VERY SHORT TREATMENT SESSION WAS
STARTED 2 MIN AND 40 SECONDS LATER AND ENDED AFTER 1 MIN AND 7 SECONDS. THE DEVICE
IS TESTED IN A FULL PRODUCTION TEST AND NO ISSUES ARE FOUND WITH THE DEVICE. CAUSE:
FAULT TRACING OF THE DEVICE COULD NOT ESTABLISH ANY HARDWARE OR SOFTWARE FAILURE ON
THE DEVICE. LOGFILE HAS BEEN REVIEWED AND THE CONCLUSION IS THAT THERE IS NO
INDICATION THAT THE DEVICE HAS SET ITSELF INTO STAND-BY. CONCLUSION AND ACTIONS
THERE IS NO INCREASING FAILURE TREND FOR THE USE ERROR OF VIVO 50 VENTILATORS. IT
WAS NOT POSSIBLE TO RE-CREATE THE FAILURE ON THE RETURNED UNIT. THERE HAS BEEN NO
PERMANENT PATIENT HARM REPORTED AS A RESULT OF THE INCIDENT. RISK MITIGATIONS
LEVEL AT TECHNICAL ALARP (AS LOW AS REASONABLY PRACTICAL) WITHOUT TAKEN ANY
ECONOMIC ASPECTS INTO CONSIDERATIONS. BASED ON THE INFORMATION PROVIDED, CONFIRMING
EXISTING MITIGATIONS ARE FOUND EFFECTIVE. THE REPORT CONFIRMS THAT ANY PATIENT
INVOLVED DID NOT SUFFER ANY SERIOUS INJURY. WE WILL CONTINUE TO TRACK AND TREND THE
ISSUE ACCORDING TO THE PROCEDURES OF OUR QUALITY MANAGEMENT SYSTEM. NO FURTHER
ACTIONS ARE PLANNED AT THIS TIME.
Malfunction|Device Operates Differently Than Expected|ON (B)(6) 2017, BREAS MEDICAL
RECEIVED INFORMATION THAT VIVO 50 S/N (B)(4) HAD BEEN INVOLVED IN AN INCIDENT IN
(B)(6). FAULT DESCRIPTION PER THE REPORTER "A TECHNICIAN WENT AT THE REQUEST OF THE
NURSE FOR A PROBLEM WITH A PATIENT'S VIVO 50. THE PROBLEM OCCURRED DURING LUNCH:
THE VIVO ALARMED BY DISPLAYING THE CODE "ERROR9" AND STOPPED ABRUPTLY AND TOTALLY.
THE NURSE DIDN'T KNOW HOW TO RESTART THE VIVO. SHE THEREFORE SWITCHED THE PATIENT
ON THE SECOND VIVO. IN THE HISTORY OF THE ALARMS WE ALSO NOTE THE ERROR CODES 21 &
9.". THE PATIENT WAS NOT INJURY DURING THE INCIDENT.|UNDER EUROPEAN LAW, PATIENT
BREAS MEDICAL (B)(4) BECAME AWARE ABOUT THIS COMPLAINT (B)(6) 2017 BUT AT THAT TIME
DID NOT ASSESS THIS AS REPORTEBLE PER OUR PROCEDURES. THERE WERE NO DEATH OR INJURY
AND THE DEVICE ACTED AS DESIGNED AND INTENDED IF AN INTERNAL FUNCTIONAL FAILURE
OCCURS, BY TRIGGERING A FAIL-SAFE SHUT-DOWN AND GIVING A HIGH PRIORITY AUDIBLE AND
VISUAL ALARM. THE ISSUE WERE REPORTED TO ANSM ((B)(6) AUTHORITY) (B)(6) 2017 AND AS
THIS IS FILE AS AN INCIDENT IN FRANCE THE FILING IS ALSO MADE IN US AS REGULATED.
INVESTIGATION THE DEVICE WAS SENT TO BREAS MEDICAL (B)(4) AND ARRIVED (B)(6) 2017.
ON (B)(6) BREAS MEDICAL (B)(4) STARTED THE EXAMINATION OF THE DEVICE. GENERAL
INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE IS IN GOOD SHAPE, NO PATIENT AIR
FILTER WAS INSTALLED IN THE UNIT WHEN RETURNED. THE DEVICE WAS STARTED AND THE
FUNCTION FAILURE ALARM WAS CHECKED, IT WORKED AS INTENDED AND THE DEVICE GAVE
AUDIBLE, WITH LEVEL FOR 85DB Â±5BD THAT CAN'T BE CHANGED OR TURNED OFF, AND VISIBLE
ALARMS. THE DEVICE HAS BEEN TESTED AND RUNNING ON INTERNAL BATTERY FOR 4 HOURS
WITHOUT ANY PROBLEMS. NO FAILURE COULD BE DETECTED. NOTE THAT THE INTERNAL BATTERY
HAS BEEN CHANGED, IT IS NOT THE ORIGINAL THAT WAS ATTACHED WHEN DEVICE WAS SOLD.
THE LOG FILES WERE DOWNLOADED AND EXAMINED WITH THE PC SOFTWARE VERSION 3.2.3.2.
THE LOG FILES COULD ESTABLISH THAT THE DEVICE HAS BEEN RUNNING ON CLICK-ON BATTERY
FROM 12:28:52 THE (B)(6) 2017. THE DEVICE SWITCHED OVER TO INTERNAL BATTERY AND 4
SECONDS LATER A POWER FAIL IS LOGGED DUE TO INTERNAL BATTERY FAILURE. THE DEVICE
TRIES TO RE-START BUT POWER FAIL IS GIVEN AND SEVERAL ERROR CODES, ERROR 21-MAIN
PROCESSOR UNABLE TO COMMUNICATE WITH PTU BOARD, ERROR 14 - MAIN BEEPER FAILS ARE
GIVEN TILL THE DEVICES STOPS WITH ERROR 9 - MAIN PROCESSOR COMMUNICATION, WITH
VISIBLE AND AUDIBLE ALARMS. ADDITIONAL TESTING: THE DEVICE HAS BEEN REPEATEDLY
TESTED WITH THE INTERNAL BATTERY THAT WAS ATTACHED WHEN THE DEVICE WAS RETURNED.
THE REPEATEDLY TESTING HAS IN THE END REPRODUCED THE INTERNAL BATTERY FAILURE THAT
ENDED UP WITH SHUT DOWN OF TREATMENT WITH THE ERROR CODE 9. THE DEVICE HAS ALSO
BEEN TESTED IN THE SAME WAY WITH ANOTHER INTERNAL BATTERY, THEN THE FAILURE HAS NOT
BEEN ABLE TO BE REPRODUCED. CAUSE: FAULT TRACING OF THE DEVICE COULD FINALLY
ESTABLISH THAT THERE IS AN INTERMITTENT FAILURE IN THE INTERNAL BATTERY. THE ERROR
9 WAS A TEMPORALLY FAILURE CAUSING THE DEVICE TO ACT AS DESIGN, SHUT DOWN WITH
FUNCTION FAILURE DUE TO A POWER FAILURE THAT RESULTED IN ERROR 9 - MAIN PROCESSOR
COMMUNICATION. CONCLUSION AND ACTIONS BREAS DO NOT AT THIS MOMENT SEE ANY
INCREASING FAILURE TREND FOR FAILURES RESULTING IN ERROR CODE #21, 14 OR 9 OF THE
VIVO 50 MODEL VENTILATOR OR INTERNAL BATTERY FAILURES. THE DEVICE HAS PERFORMED AS
DESIGNED AND INTENDED IF AN INTERNAL FUNCTIONAL FAILURE OCCURS, BY TRIGGERING A
FAIL-SAFE SHUT-DOWN AND GIVING A HIGH PRIORITY AUDIBLE AND VISUAL ALARM. THERE HAS
BEEN NO PATIENT HARM REPORTED AS A RESULT OF THE INCIDENT. RISK MITIGATIONS
LEVEL AT TECHNICAL ALARP (AS LOW AS REASONABLY PRACTICAL) WITHOUT ECONOMIC ASPECTS.
BASED ON THE INFORMATION PROVIDED, CONFIRMING EXISTING MITIGATIONS ARE FOUND
EFFECTIVE. THE REPORT CONFIRMS THAT ANY PATIENT INVOLVED DID NOT SUFFER ANY SERIOUS
INJURY. WE WILL CONTINUE TO TRACK AND TREND THE ISSUE ACCORDING TO THE PROCEDURES
OF OUR QUALITY MANAGEMENT SYSTEM. THE INTERNAL BATTERY WILL BE REPLACED, NO FURTHER
ACTIONS ARE PLANNED AT THIS TIME. THIS INCIDENT HAS ADDITIONALLY BEEN REPORTED TO
THE FRENCH NATIONAL COMPETENT AUTHORITY ANSM, IN MANUFACTURER'S VIGILANCE REPORT TO
ANSM WITH REFERENCE NUMBER (B)(4).
AN ASTRAL DEVICE DISPLAYED A RED SCREEN AND FAILED TO RESTART AFTER A SOFTWARE
UPGRADE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DETERMINED THAT THE RED SCREEN AND THE DEVICE FAILURE TO RESTART WAS DUE TO A
SOFTWARE UPGRADE FAILURE. THE SOFTWARE WAS REINSTALLED TO ADDRESS THIS ISSUE.
(B)(4).
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD
PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE EVALUATION DETERMINED THAT
THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE NON-
RETURN VALVE (NRV) WITHIN THE PNEUMATIC BLOCK. THE NRV ASSEMBLY WAS REPLACED TO
Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD BATTERY
AUTONOMY ISSUES. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS
INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE
RESMED IS UNABLE TO CONFIRM THE REPORTED EVENT AT THIS TIME. (B)(4).
INTERNAL SELF-TEST WAS DUE TO A NON-RETURN VALVE (NRV) ISSUE WITHIN THE PNEUMATIC
BLOCK. THE NRV ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS
Melted;Power Problem|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE DISPLAYED AN
INTERNAL BATTERY INOPERABLE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS
THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT BEEN
RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE REPORTED EVENT AT THIS TIME.
(B)(4).
DISPLAYED AN ERROR MESSAGE (SF219) RELATED TO A PB ERROR. THERE WAS NO PATIENT
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE/ DATA LOGS WAS RETURNED TO
ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF180) RELATED TO A BATTERY CHARGER
DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND
FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR
(4).
Event Without Identified Device or Use Problem|IT WAS REPORTED TO RESMED THAT A
PATIENT USING AN ASTRAL DEVICE EXPIRED. THERE IS NO REPORTED ALLEGATION OF
MALFUNCTION. PER THE POLICE INVESTIGATOR, THE PATIENT WAS DISCONNECTED FROM THE
TRAVEL VENTILATOR AND CAREGIVER COULD NOT GET THE PATIENT TO HER HOME VENT BEFORE
THE PATIENT STARTED TURNING BLUE. CPR WAS INITIATED. EMERGENCY SERVICES ARRIVED AND
THE PATIENT WAS TRANSPORTED TO THE HOSPITAL.|RESMED HAS REQUESTED FOR THE DEVICE TO
NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO DETERMINE IF THE DEVICE
MALFUNCTIONED AT THIS TIME. RESMED REFERENCE PR #: (B)(4).
Failure to Calibrate;Battery Problem|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD
A FAULTY INTERNAL BATTERY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION
CONFIRMED THE COMPLAINT. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE.
THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER.
7746021||NOU|Continuous, Ventilator, Home Use|27943|BLOC ALIMENTATION - ASTRAL|
Malfunction|Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL POWER SUPPLY
UNIT (PSU) WAS INOPERABLE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS
A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD
PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE CUSTOMER WAS ISSUED WITH A
REPLACEMENT POWER SUPPLY UNIT (PSU) AS PART OF A WARRANTY CLAIM. RESMED'S RISK
ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4)
Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO CHARGE
ITS INTERNAL BATTERY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION
CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4)
COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM OR SERIOUS INJURY
EVALUATION CONFIRMED THE COMPLAINT. THE NON-RETURN VALVE (NRV) ASSEMBLY WAS
REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT
EVALUATION CONFIRMED THE COMPLAINT. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE
ACCEPTABLE. (B)(4).
Power Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A POWER SOURCE
DETECTION ISSUE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT
OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE
COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE
WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
ACCEPTABLE. (B)(4).
ACCEPTABLE. (B)(4).
Malfunction|Protective Measures Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE DISPLAYED AN ERROR MESSAGE (SF147) RELATED TO A STALLED MAIN BLOWER. THERE
WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION
METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. WHEN MORE
INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)
FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT HARM OR SERIOUS
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN
AUTHORIZED RESMED THIRD PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE
COMPLAINT. THE NON-RETURN VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE.
(B)(4).
ACCEPTABLE. RESMED REFERENCE (B)(4).
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN
INTERNAL BATTERY FAULT. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD
PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE INTERNAL BATTERY WAS
REPLACED AS A PRECAUTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME,
THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. (B)(4).
8087167||NOU|Continuous, Ventilator, Home Use|19620|ASTRAL BATTERY PACK|
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE SWITCHED
FROM EXTERNAL TO INTERNAL BATTERY BEFORE IT WAS COMPLETELY DEPLETED. THERE WAS NO
PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE
WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. THE REPORTED FAILURE COULD
NOT BE REPRODUCED DURING EVALUATION. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED
AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE
RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED
COMPLAINT. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A
SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS DUE TO AN
ISOLATED COMPONENT FAILURE WITHIN THE DEVICE MAIN CIRCUIT BOARD (PCBA). RESMED'S
Failure to Power Up|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE DID NOT TO POWER ON.
THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|
THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE
MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND
POWER SOURCE DETECTION ISSUE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED
AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE
NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL
REPORT WILL BE SUBMITTED. RESMED REFERENCE #: (B)(4).
EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS
AN EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO
ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED
Display or Visual Feedback Problem|IT WAS REPORTED TO RESMED AN ASTRAL DEVICE HAD A
FROZEN SCREEN AND WAS INOPERABLE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY
EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS
Battery Problem;Protective Measures Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE DISPLAYED AN INTERNAL BATTERY ERROR MESSAGE. THERE WAS NO PATIENT
HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS
RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE INTERNAL BATTERY
WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE
POWER SOURCE DETECTION ISSUE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED
CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THIS ISSUE.
NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL
REPORT WILL BE SUBMITTED. (B)(4).
Inadequate User Interface|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN
UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A
RESULT OF THIS INCIDENT.|THE DEVICE WAS RECEIVED BY AN AUTHORIZED RESMED THIRD
PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE TOP CASE WAS
REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT
RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD
PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE DEVICE SOFTWARE
WAS UPGRADED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE
CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: ( B)(4).
ITS INTERNAL BATTERY AND HAD A TOTAL POWER FAILURE EVENT. THERE WAS NO PATIENT HARM
OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO
A AUTHORIZED RESMED THIRD PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE
COMPLAINT. THE DEVICE SOFTWARE WAS UPGRADED TO ADDRESS THIS ISSUE. THE DEVICE WAS
SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK
Failure to Calibrate;Protective Measures Problem|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED AN ERROR
MESSAGE (SF188) RELATED TO A SAFETY SYSTEM ASSERT FAULT. THERE WAS NO PATIENT HARM
RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS
AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE #: (B)(4).
Protective Measures Problem;Failure to Calibrate|IT WAS REPORTED TO RESMED THAT AN
ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED AN ERROR
MESSAGE (SF115) RELATED ATMOSPHERIC PRESSURE MONITORING. THERE WAS NO PATIENT HARM
RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE DEVICE WAS RECALIBRATED TO
Premature Discharge of Battery;Battery Problem|IT WAS REPORTED TO RESMED AN ASTRAL
DEVICE DISPLAYED A BATTERY ERROR MESSAGE AND HAD A REDUCED LEVEL OF CAPACITY. THERE
WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE
INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND
(4).
Failure to Charge;Failure to Shut Off|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY AND FAILED TO POWER DOWN. THERE WAS NO
PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS
REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD
BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO
CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
Battery Problem;Protective Measures Problem|IT WAS REPORTED TO RESMED AN ASTRAL
DEVICE DISPLAYED A BATTERY ERROR MESSAGE. THERE WAS NO PATIENT HARM OR SERIOUS
INJURY REPORTED AS A RESULT OF THIS INCIDENT.|RESMED HAS REQUESTED FOR THE DEVICE
TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE
HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED
MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).
Failure to Calibrate;Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY AND COMPLETE ITS INTERNAL SELF-TEST.
MAIN CIRCUIT BOARD, INTERNAL BATTERY AND PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
Failure to Calibrate||
Failure to Calibrate;Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL
DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY AND COMPLETE ITS INTERNAL SELF-TEST.
MAIN CIRCUIT BOARD, INTERNAL BATTERY AND PNEUMATIC BLOCK WAS REPLACED TO ADDRESS
ACCEPTABLE. (B)(4).
Protective Measures Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
DISPLAYED AN ERROR MESSAGE (SF218) RELATED TO A MAIN BOARD ERROR. THERE WAS NO
WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION
AND SERVICE. THE CUSTOMER WAS ISSUED WITH A REPLACEMENT NON-RETURN VALVE (NRV) AND
INTERNAL BATTERY PACK AS PART OF A WARRANTY CLAIM. RESMED'S RISK ANALYSIS FOR THESE
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED TO AN AUTHORIZED
RESMED THIRD PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE
NON-RETURN VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS
RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE NON-RETURN VALVE (NRV)
ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY
RESMED SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE NON-RETURN
VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED
AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR
DISPLAYED AN ERROR MESSAGE (SF218) RELATED TO A MAIN BOARD ERROR. THERE WAS NO
WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION
AND SERVICE. THE CUSTOMER WAS ISSUED WITH A REPLACEMENT NON-RETURN VALVE (NRV) AND
INTERNAL BATTERY PACK AS PART OF A WARRANTY CLAIM. RESMED'S RISK ANALYSIS FOR THESE
RESMED SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE NON-RETURN
VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED
AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR
(4).
DISPLAYED AN ERROR MESSAGE (SF101) RELATED TO PRESSURE MEASUREMENT. THERE WAS NO
WAS RETURNED TO AN AUTHORIZED RESMED (B)(6) CENTER FOR AN EVALUATION AND SERVICE.
NO INFORMATION IS AVAILABLE AT THIS TIME, THEREFORE RESMED IS UNABLE TO CONFIRM THE
ALLEGED MALFUNCTION. (B)(4).
Protective Measures Problem||
Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE POWERED DOWN
UNEXPECTEDLY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE
COMPLAINT. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS
Failure to Calibrate;Protective Measures Problem;Battery Problem|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THERE WAS
NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE
DEVICE TO RETURNED TO RESMED AND AN INITIAL EVALUATION CONFIRMED THE COMPLAINT.
WHEN MORE INFORMATION IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED
REFERENCE # (B)(4).
Malfunction|Failure to Power Up|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DID
NOT POWER ON. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF
THIS INCIDENT.|THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE
COMPLAINT. VISUAL INSPECTION OF THE DEVICE REVEALED WATER DAMAGE. CUSTOMER DECLINED
REPLACEMENT OF THE PNEUMATIC BLOCK AND MAIN CIRCUIT BOARD TO ADDRESS THE ISSUE. THE
DEVICE WAS RETURNED TO THE CUSTOMER UNREPAIRED. RESMED'S RISK ANALYSIS FOR THIS
Malfunction|Power Problem||
Malfunction|Failure to Calibrate;Protective Measures Problem|IT WAS REPORTED TO
RESMED THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND
DISPLAYED AN ERROR MESSAGE (SF 131) RELATED TO THE MAIN BLOWER TEMPERATURE SENSOR.
THE DEVICE WAS RETURNED AND AN EVALUATION COULD NOT CONFIRM THE REPORTED SF 131.
THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THE FAILED TO COMPLETE ITS INTERNAL
SELF-TEST THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE
CUSTOMER. RESMED'S RISK ANALYSIS FOR THE FAILURE MODE CONCLUDES THAT THE RISK IS
ACCEPTABLE. (B)(4).
Malfunction|Failure to Charge|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE
FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY
REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED AND AN EVALUATION
CONFIRMED THE COMPLAINT. REVIEW OF THE DEVICE DATA LOGS REVEALED AN INTERNAL
BATTERY ALARM. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE
WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. BASED ON ALL
AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE
INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO A SOFTWARE ISSUE.
RESMED'S RISK ANALYSIS FOR THE FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.
(B)(4).
Failure to Calibrate||
Malfunction|Failure to Calibrate||
Protective Measures Problem;Battery Problem||
Malfunction|Failure to Calibrate||
Malfunction|Failure to Charge||
Protective Measures Problem||
Malfunction|Protective Measures Problem||
Power Problem||
Protective Measures Problem;Battery Problem||
AN EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO
TO THE CUSTOMER. (B)(4).
Malfunction|Failure to Charge||
9708967||NOU|Continuous, Ventilator, Home Use|27918|BATTERIE EXTERNE ASTRAL|
Malfunction|Battery Problem|IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN
EXTERNAL BATTERY WITH REDUCED LEVEL OF CAPACITY. THERE WAS NO PATIENT HARM OR
SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.|THE DEVICE WAS RETURNED AND
AN EVALUATION CONFIRMED THE COMPLAINT. THE CUSTOMER DECLINED SERVICE AND THE
EXTERNAL BATTERY WAS SCRAPPED. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT
INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED
COMPLAINT WAS DUE TO A DEFECTIVE EXTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR THESE

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