PHILIPS Cardiac Resuscitation — FSN86100074 2008 July URGENT - Medical Device Correction M3535A/M3536A HeartStart MRx Internal Memory Cards in Some Units May Cause Device Restart Philips Healthcare Dear Customer, This letter is to inform you that Philips Healthcare is conducting a voluntary correction of approximately 500 HeartStart MAx Monitor/Defibrillators. Philips has determined that these devices may cont defective internal memory cards that can cause the devices to exhibit one or more of the following behaviors: * Device repeatedly restarts approximately every 20 seconds. * Slow device start-up of approximately 15 seconds or more. During this time, the MAx displays either ‘a blank screen or the Philips HeartStart MAx Start-up screen prior to displaying the selected mode of ‘operation (i.e. Monitor, AED, Pacing or Manual Defit mode). ‘+ ‘Internal Memory Failure” INOP message when attempting to print an event from the Data Management screen. ‘© When printing from the Data Management screen, a patient's Event Summary prints with some clinical events missing. This document contains important information for the continued safe and proper use of your equipment Please review the 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. Please retain a copy with the equipment Instruction for Use. (ur records indicate that you have received at least one of the affected devices, which were originally shipped from Philips’ manufacturing facil in the first half of 2008. Please see the table on page 2 of this notice, which provides information on how to identify affected devices and instructions on actions to take. Philips has traced the source of the problem to one group of potentially defective internal memory cards, land we are voluntarily initiating a correction of affected devices by replacing these cards. Philips will replace the cards free of charge. We apologize for the inconvenience that this will cause you. Ensuring that you have the highest quality defibrillators is our top priority. Your satisfaction with Philips products, as well as with our response to this problem, is very important to us. If you need any further information or support concerning this issue, please contact your local Philips Response Center at 0180 3333544. Sincerely, ctor, Quality & Regulatory Affairs, Philips Cardiac Care ‘This notice has been raported tothe appropriate Regulatory Agency. Page 1 of 5PHILIPS Cardiac Resuscitation ~ FSN86100074 2008 July AFFECTED PRODUCTS Product: Philips HeartStart MRx Monitor/Defibilators, Models M5354 and M5364. Units Affected: See Units Affected List on pages 3 and 4. Manufactured and Distributed by: Philips Healthcare, 3000 Minuteman Road, Andover, MA 01810 PROBLEM DESCRIPTION Devices with defective internal memory cards can exhibit one or more of the following behaviors: * Device repeatedly restarts approximately every 20 seconds. ‘+ Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start- up screen prior to displaying the selected mode of operation (.2. Monitor, ‘AED, Pacing or Manual Defib mode). © “Internal Memory Failure” INOP message when attempting to print an event from Data Management. ‘+ When printing from the Data Management screen, a patient’s Event ‘Summary prints with some clinical events missing. HAZARD INVOLVED Devices exhibiting the repeated restarts behavior are unusable for monitoring, defibrillation, and pacing. HOW TO IDENTIFY AFFECTED PRODUCTS To determine whether you have an affected device, locate the serial number on the back of the MRx, in battery bay B, and determine if itis on the Units Affected List on pages 3 and 4 of this notice. ‘ACTIONS PLANNED BY PHILIPS Philips wil replace the internal memory cards in affected MRx Moritor/Defibrilators free of charge. ‘A Philips Healthcare representative wil contact customers with devices on the Units Affected List to arrange for replacement ofthe internal memory card ‘ACTION TO BE TAKEN BY CUSTOMER / USER During the interim period, as you await the upgrade for your device, you may continue to use the HeartStart MRx. However, itis advised that you have a readily available backup defibrillator to use should the restart behavior occur. Devices that exhibit the repeated restart or slow start-up should be removed from service. Devices that exhibit the incomplete Event Summary or Internal Memory Failure printing behavior may remain in service if your application does not require the information in the Event Summary. ‘Additionally, Philips recommends that users check the Stalus Log for an error "0x80000102" at each shift check and remove the device from service if the error is present. This error indicates the potential for the restart behavior. Instructions {for accessing the Status Log are on page § of this Medical Device Correction Notice. FURTHER INFORMATION AND SUPPORT If you need any further information or support conceming this issue, please ‘contact your local Response Center at 0180 3333544, Page 2 of 5PHILIPS Philips Healthcare Cardiac Resuscitation FSN86100074 2008 July Units Affected List (us00100604 1us00324716. 1ys00324864 ‘us00s24848 lusoasese64 1ys00326784 1¥500100695, 1us00324720 1¥S00324855, 1yso0g24849 1us00s25674 1us00325767 1us00101003. uso0324727_ 1US00324856 1ys00324950 ~us00825675 'u500325766, 1yso0101149. uso0s24728 1ys00324858, 1ys00324951 1uso0325676 'uS00325769 'ys00101277_ 1uso0324729 1us00324969 uso0324952 1us00325677 'us00925790 1ys00101427_ 1ys00320730, 1ys00324860. 1uso0924954 1ws00325678 1ys00325795: 1uso030144a us00324731 1us00324861 1y500324956. ‘uso0325679 'y00325796 1ys00301696 'ys00324734 tuso0324862, 1us00324057 'us00325680 1us00325797, 'ys00101876 {y300324736 1us00324863, 1us00324955 1ys00325681 1ys0035799) 'us0010203 1us00324744 us00324864. usoca24959 usoos2se82 1us00325800. 1ys00102552 'us00324748 us00324865 usoca24961 1ys00325689 1us00925804 ‘uso0102602 1uso0324749 uso0324a65 vusoosates2 | _uso0s2s6e4 1U500525806 uso0202756 1yS00324751 uso0324a67_ US00s24963, ‘us00325685 1ys00325807. us0c207065 ‘uso0s24764, 1ys0024865, 1ws00324964 1y500325686. usoos2se08 1us00203505 {us00324766. 1y00324869 1ys00324965 1ys00325667_ 1us00325810 1ys00203923 1uS00324758. 'ys00324870. 'ys00924966 us00325888 1ys00325612 ys00204295 1ys00324759, 1y500324671 'ys00324967 uso0a25689 1us00325813 ‘uson204a47_ 1us00324760_ 'ys00324872 1ys00324968 'us00325690 us00325814| ‘uson204a61 1us00324761 1ys00324873, 1ys00324970 1uso0s25692 1ys00225016 ‘uson204623 uso0324769 1ys00324874 1ys00324971 ‘uso0s25604 1ys00225617 1uson2044ae us0032764 1ys00324875, 1ys00324075 'ys00s25606 'ys00925816 ‘usonz04490 uso0s24765, 1us00324876, 1us00324974 1us00525607 'ys00925819 ~uso020464e usoasee767 | usoosess77 1us00324975; 1uso0s25e08 'y300325820 1ys00205100 1us00324766 1ys00924678, ‘uso00924978 ‘usooa2se09 1ys00325621 ‘ysoc205625 'ys00324769 1ys00924878 tusoas24900__ | _uso0%26700 ‘usona25822 usoc2oseae 1us00324771 1us00324860 1uso0s24982 tyso0325701 1us00325820 ‘usoc205650 'us00924773) 1uso0324084 usoas249@4 tusoo32702 1uso0925827 ‘uso0205651 1ys00924775. tuso0s24882 uso0s24996 usoos2s704 1us00225828 ‘usoc20s660 'ys00324777 1ys00324883 uso0324997 1ys00325705 1ys00925850 1us00205668 'ys00324779 ‘us00s248s 'us00325003 vs00s25706 us00325891 usoc2osess 1ys00324780. ys00324885, 1ys00325005 ys00s26707 ‘uso0325832 1us00205753 1ys00324781 ‘ys00324686 'ws00325007 1ys00326708 1ys00325853 1ys00205833 ‘yso0s24762 ‘ys00024697 ‘ws00325008 1ys00325709 1ys00325894 ‘us00205904 'yS00324763, ‘usoos2aese | usvoaasoi0 | _uso025710 1ys00325835 ‘ys00206%44 1us00324784 1y3s00324889 1ys00926023__| __usooa26711 uso0a2s896 ‘uson206s01 ‘uso0a24785 1ys00324890 1uso0g25024 | uso0s25712 'us00325697 ‘uson206ét 1us00324786, 1y00324891 1us00326028 1ys00325713 1uso0s25838 'ys00207021 uso0324789. 1ys00224892. 1us00325031 1ys00325714 ‘us00325647 'yso00207313. uso0324769, 1ys00324893, 1us00325032 us00325715 1us00325648 1ys00207485 tuso0s24802_ 1ys00s24804 'uS00925035 us00325716 1ys00325851 1uson207604 1ys00324803 1ys00324805 vyso0s25038 | __usvoa2s717 ys00325852 1ys00207024 us00224804 1y00324805 1uS00325040 ‘uso0s26716 1ys00325855, 1ys00207990. 1y300924905. vusoov2es97 | _ uso0x2sos1 1ys00s25719 'y300325656 1uso0208087 1y300324806 1ys00324898 1yso0325042 us00325720 1us00325858 Page 3 of 5PHILIPS Philips Healthcare Cardiac Resuscitation FSN86100074 2008 July Units Affected List (continued) ‘usoc708140 ‘ys00328807 1y500924899 1us00s25043 {us00325724 ‘usona2sase 'us00208752 'ys00324806 1yS00324900 1us00325045, 1ys00325722, us00925864 1us00206789 {y300324809 1ys00324901 yso0s25046, 1us00325723, uso0325069 1us00206720 1ys00324610. 1ys00924002, tuso0s25049 1us00325724 1us00325067 1ys00208385 'ys00324811 1y00324003 tus00s25054 1us00325725 'us00325670. us00200715 1us00224812. 1ys00324904 uso0225055 1us00325726 us00325871 usoo210189 1ys00224613 1ys00324905. 'us00325056 uso0325728 ys00325873 uso0210304 1ys00324814 1y00524006. 'us00325087 ys00325729 1y300325674 1ys00210763, 1ys00324815, 1y500524007, 1us00325062 'ys00325730. 1y300325075, ‘ys002 10982, 1us00324816, 1us00924908, ys00325063, us00926731 ‘ys0022507 uson212242, 1uso024617, 1ys00324900 ‘us00326064 us00325754 'ys00925676. 1us00212780, 1us00324816: 'ys00924910 'u30025066. 1ys00325735, 'y300325889 1us00315280 1us00324819 1ys00324911 1ys00325066. 1us00325736 1¥300325003, 1ys003 15647. 1us00324820 1ys00324012 'ys00325060 1us00325737_ 1y300325008, 1ys00315464 tuso0324821 1ys00324913 'ys00325081 us00225738 'us00225000 1y300916050_ uso0s24822, 1yso0924014 1ys00325082 1ys00325739, 1ys00325043, 'us009 18057. us00324823 ‘yso0324916. 'ys00225085 ‘uso0225740, 'ys00225067, 'uso00918629 uso0s24824 1us00324916. {¥s0025006 uso0326741 'ys00025979 'ys00918598, 1us00324825 1ys00924017, 'ys00325087 1us00s25742 'y300325004 1ys009 19996. 1us00324826 1ys00924918 'ys00325006 1us00s2s744 1ys00326002 1ys00321428 1uso0324827, 1ys00324919 'y300325005, us00325745 1us00326008 1ys00s24554 usooszt828 1uso0a24820 'us00325096, uso0a25746 ‘usona26004 'ys00s24561 1uso0324829 tusoos24821 1ys00325166, uso0325748 1uso0226043 usona245e2 1us00324830 usons24922 1ys00925201 1us00326749 1us00226058 vuso0324589 uso0324831 1us00324929 1ys00325534 1ys00325760 'ys00226061 vusona24504 soos24632. tusoas24924 1ys00925635 us00326751 'ys00326062 ‘uso0324596 uso0324893 1ys00324025 1uS00025685 ys00325752 1¥S00326063 1ys00324614 1ys00324834 1uso0324926 1us003255864 'u00025759) ‘usong26064 1ys00324615 1us00324895, 1yso0324927 us00925685, 1ys00925754 ‘yso00926065, 1uso0a246%6 us00324836. 1uso0324926 1yS00525586 us00325755 1ys00326069 'uso0324619 uso0324897_ tuso0s24929 1us00925687 1uso0a25767 1us00926073 'uso0s24620 uso03ees8 tusooa24932 1us00925612 uso0a2575e ‘uso0a26074 usoas24622 usooa2eat 1ys00324933 1us00325613 us00228759 'us00326075, uso0a24624 uso0324642_ 1uso0s24034 1us00325616: 1uso0325762 'us00926079. uso0s24625 vuso0324649 uso0s24035 1ys00925621 us00326763 ‘usona26004 1us00a24627 vysoog2e6s 1us00324036 1ys00325623, ys00325766 1ys00926225 uso0s24642 uso0s2es45, 1yso032¢097 1ys00325624 1ys00326767 ‘ys00926248 us00s24645 ys00324647 tus00s24038 1ys00325626, 'u500325768. 1ys00326350 tuso0s24646 uso0324848) 1uso032¢839 1us00325651 'us00225770. 'us00025505 tuso0s24e69 yso9324849| usooa24040 usons25654 1us00925771 vusocs2eee9 | _usooszeaso 1us00324041 {uS00525855, 1y300325773, 1ys00s24707 1ys00324851 ys00s24042 1us00325651 1us00925774 vuso0a2e712 1uso0324852 ‘ys00224044 usoas25662 'us00225775 vuso02e713 1ys00324853 ‘ysn024947, 1uso00325663 uso0s2s780__ | Page 4 of 5PHILIPS Philips Healthcare diac Resuscitation FSN86100074 2008 July Instructions for Checking the Status Log Check the HeartStart MRx Status Log through Service Mode. CAUTION: Do not access Service Mode while the HeartStart MRx is connected to. a patient. To access the Status Log: 1. Turn the HeartStart MRx Therapy Knob to Monitor 2. Press the Menu Select button 3. Use the Navigation arrows to highlight Other and press the Menu Select button 4. From the Other Menu highlight Service and press the Menu Select button ‘You are now leaving normal operating mode and need to press the Menu Select button to acknowledge the on-screen message 5. Enter the password (27689) by using the Navigation arrows to scroll through the list of numbers until the desired number is highlighted. Press the Menu Select button to activate each selection 6. Once you have entered all five numbers, select Done and press the Menu select button 7. Once in Service Mode, press the Menu Select button to activate the Service Menu. Use the Navigation arrows to highlight Status Log and press the Menu Select button 8. Ifthe IntelliVue Net option is installed, then you will be offered a choice between the Device Status Log and Network Status Log. Select Device Status Log. 9. The Status Log will appear on screen. Press the Print Log softkey to print the report To exit the Status Log and ... * return to Monitor Mode: Press the Main Service softkey and then Exit Service softkey + turn the HeartStart MRx off: Turn the Therapy Knob to the Off position NOTE: The Status Log is generally for use by trained service personnel and factory engineers. There may be many status messages in the log. Usually these messages are benign and do not require intervention. if your MRx displays an hour glass in the Ready For Use Indicator, these messages should be of no concern, other than the 0x80000102 message identified in this notice. Page 5 of 5