Philips Healthcare

FIELD CHANGE ORDER Service

Issued by : PM-B, Christoph Schneider FCO Ref No. : FCO86201725A

Supersedes : N/A Date : 20-Jul-2016

TITLE : FCO86201725A: IntelliVue MX400 – 550 show outdated wave drawings

CLASSIFICATION: Specify one classification.

_ X _ Mandatory Action
____ Action for Performance – Proactive
____ Action for Performance – Retrofit on Failure
____ Service Recommendation

APPLIES TO:

Geography : Worldwide

Traceable Item Identification PMS Number Part Number:

866060 866060
866061 866061
866062 866062
866064 866064
866066 866066
Range of Serial Numbers See UAL
Commercial (Sales) Product Number PMS Number Part Number:
866060 866060
866061 866061
866062 866062
866064 866064
866066 866066

LIST OF PAGES & DRAWINGS:

N/A

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 1 of 7
INTRODUCTION:
Symptom : If the monitor has been used continuously for a longer period of time, without turning off or power cycling
the device, the waveforms show outdated wave data instead of actual real-time data.

Note: Alarming and other functionality work as specified. Numerics representing vital signs are showing
current values.

The length of time that a monitor must be powered on before the problem occurs depends on the
selected wave speed. It ranges from 102 days (@ 50 mm/s) to 820 days (@ 6,25 mm/s), and is
approximately 205 days at the monitor’s default wave speed of 25 mm/s.

The monitor must be powered off in order to avoid this problem. Simply placing it in stand-by mode is
not sufficient.

Cause : The above-described symptom is caused by a software deficiency within the IntelliVue software versions
K.0, K.1, K.2, and L.0.

Remedy : Software patches K.21.46 and L.01.10 correct the issue described above.
Please refer to “Procedure‟ for upgrading the unit.

MANPOWER / TIME TO COMPLETE:

Implementation:
0.5 Hours
1 Engineers

Implementer:
Philips Engineer or Approved Service Provider
Customer
No Engineer Required

TOOLS & TEST EQUIPMENT:

Support Tool version L.01.02 (or higher).

Earlier versions of the Support Tool are no longer supported. Do not use earlier Support Tool versions to service/upgrade
an IntelliVue monitor.

Further information concerning Support Tool release L.01.02 is available in the following service bulletin:
“SB86202445A: 862401/M3086A Support Tool Release L.01.02 is now available”.

MODIFICATION KIT / PARTS REQUIRED:

N/A

PROCEDURE:
Location Category: Check one. __X__ On-site __X__ Philips Medical CRC
__X__ Customer Installable __X__ Remote

1. With Support Tool Mark2 L.01.02 (or higher) upgrade the affected devices:
Device from SW version to SW version
866060/62/64/66 K.xx.xx K.21.46 (or higher)
866060/61/62/64/66 any version < L.01.10 L.01.10 (or higher)

Note: The upgrade must be done to L.01.10 in all countries that have regulatory approval to L.0 software. The
K.21.46 version is only to be used in countries where L.0 does not have regulatory clearance.

When upgrading device software to a new major revision you must ensure that a printed version of the
Instructions for Use (IfU) of the respective software is made available for the end user as part of the upgrade
process; versions of the IfU that are no longer applicable have to be replaced. The IfU of the respective
software can be downloaded here or can be ordered via the respective software upgrade, option #DCL.
Furthermore, the end user must receive adequate user training.
Before installing software in any patient monitoring device, check with your sales representative, dealer or
Philips Medical Systems to ensure that the software version has regulatory approval in your country.

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 2 of 7
 2. Perform the following verification procedures upon completion of the upgrade process:
a. Visual Inspection: V:P
b. Power On: PO:P
c. Verify the software revision installed
i. Select the Main Setup smart key on the monitor
ii. Select Revisions and then Product
iii. Verify that the SW Rev is according to table above

PARTS DISPOSAL:
N/A

DUE DATE:
The Due Date for this FCO is one year after its release.

DOCUMENTATION:
IntelliVue Support Tool Instructions for Use
If you did not change the default settings while installing the Support Tool, the Support Tool Instructions for Use can be
found on your PC under “Start -> All Programs -> Philips -> M3086A Support Tool -> Support Tool IfU”.

EC Number: B300-2016-07-21286

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 3 of 7
Field Safety Notice

Philips Healthcare
Patient Monitoring -1/3- FSN86201725A 2016 July 20

URGENT - Medical Device Correction

Outdated waveform display on Philips IntelliVue Patient Monitors

MX400, MX430, MX450, MX500, MX550

Dear Customer,

A problem has been detected with certain Philips IntelliVue Patient Monitors that, if it were to occur, could
pose a risk for patients. This Field Safety Notice is intended to inform you about:
 what the problem is and under what circumstances it can occur
 the actions that should be taken by the customer / user in order to prevent risks for patients or users
 the actions planned by Philips to correct the problem.

This document contains important information for the continued safe and
proper use of your equipment
Please review the following information with all members of your staff who need to be aware of the
contents of this communication. It is important to understand the implications of this communication.

Philips has recently determined that when certain patient monitors (MX400, MX430, MX450, MX500, MX550)
have been powered on continuously for at least three months, the waveforms displayed on the monitor may
be outdated and therefore fail to reflect the patient’s current condition. Should this occur, however, the
monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect
current patient data.

Please refer to the following pages, which provide information on how to identify affected devices and
instructions for actions to be taken. Follow the “Action to be taken by Customer/User” section of the notice.
This issue has been reported to the appropriate regulatory agencies.

I sincerely regret the inconvenience that this may cause you. Your satisfaction with Philips’ products and with
our response to this issue is very important to us. Please contact your local Philips representative
<Philips representative contact details to be completed by the KM / country> with questions or concerns
about this correction.

Sincerely,

Hauke Schik
Director of Quality & Regulatory Affairs

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 4 of 7
Field Safety Notice

Philips Healthcare
Patient Monitoring -2/3- FSN86201725A 2016 July 20

URGENT - Medical Device Correction

Outdated waveform display on Philips IntelliVue Patient Monitors

MX400, MX430, MX450, MX500, MX550

AFFECTED PRODUCTS All units of the following models of Philips IntelliVue Patient Monitors are
affected by this correction:

Model Product
MX400 866060
MX430 866061
MX450 866062
MX500 866064
MX550 866066

PROBLEM If an affected Patient Monitor has been powered on continuously for several
DESCRIPTION months, any displayed waveforms will contain outdated data and therefore fail to
reflect the patient’s current condition.

Even if outdated waveforms are displayed as a result of this problem, the monitor’s
alarms and numeric displays of vital signs will continue to function as specified
and accurately reflect current patient data.

The length of time that a monitor must be powered on before the problem occurs
depends on the selected wave speed. It ranges from 102 days (@50 mm/s) to
820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default
wave speed of 25 mm/s.

The monitor must be powered off in order to avoid this problem. Simply placing it
in stand-by mode is not sufficient.

HAZARD INVOLVED Clinical decisions based on outdated waveform morphology may result in the
administration of inappropriate therapy or a delay in the administration of
appropriate therapy.

HOW TO IDENTIFY The Product Number is contained on the devices product label, located on the
AFFECTED PRODUCTS back of the device.

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 5 of 7
Field Safety Notice

Philips Healthcare
Patient Monitoring -3/3- FSN86201725A 2016 July 20

URGENT - Medical Device Correction

Outdated waveform display on Philips IntelliVue Patient Monitors

MX400, MX430, MX450, MX500, MX550

ACTIONS PLANNED BY Philips is voluntarily initiating a correction consisting of:

PHILIPS • Distribution of this Field Safety Notice (FSN).
• A Software upgrade for affected Philips IntelliVue Patient Monitors.

A Philips Healthcare representative will contact customers with affected devices

to arrange for the installation of the software upgrade.

ACTION TO BE TAKEN Until your software is upgraded, users should cycle the power on affected
BY CUSTOMER / USER devices on a monthly basis, especially if you usually do not completely switch off
the device when no patients are monitored.

Please review this information with all members of your staff who need to be
aware of the contents of this communication. It is important to understand the
implications of this communication.

FURTHER If you need any further information or support concerning this issue, please
INFORMATION AND contact your local Philips representative <Philips representative contact details to
SUPPORT be completed by the KM/country>

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 6 of 7
FCO ACTION NOTIFICATION REPORT (ANR form)
For Key Market use only; do not return to BU/BL.
TITLE: FCO86201725A: IntelliVue MX400 – 550 show outdated wave drawings

CLASSIFICATION: Mandatory Action FCO REF. NO.: FCO86201725A

APPLIES TO: 866060, 866061, 866062, 866064, 866066

HOSPITAL / ADDRESS:

LOCATION / FW SITE NO.: SALES ORDER NO. / OA NO.:

PRODUCT NUMBER:

UNIT SERIAL NUMBER:

ACTION ON THIS UNIT WAS: (select one) JOB NO. / SERVICE INCIDENT NO.:

Completed per instruction on

DATE
Completed by the factory prior to delivery

Not completed as this unit is not affected per instruction because: (state reason)

Not completed because: . . . . . . . . . . . . .

Required parts & instructions are received by the customer

Not completed because customer refuses to install FCO: (state reason)

CUSTOMER ACKNOWLEDGEMENT (Required for MANDATORY ACTIONS only).

The REASON and PURPOSE of this modification has been explained to me.

CUSTOMER NAME (PLEASE PRINT) TITLE

CUSTOMER SIGNATURE DATE

BRANCH SERVICE UNIT /

REGION / SERVICE AREA NO.:
DEALER:

SIGNATURE CUSTOMER SERVICES ENGINEER DATE

SIGNATURE CUSTOMER SERVICES MANAGER MAIL TO: Country Customer Services manager

(Template Document Number: A-Q2920-00108-T1, Rev. R)

Field Change Order Document Number FCO86201725A Rev. A Page 7 of 7