And Then There's MAUDE (EECS 598-008 homework)
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Keywords used to find the reportManufacturerProduct name/purposeYearYour analysisURL of the MAUDE report
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buffer overflowCardiac ScienceAED2010AED firmware is vulnerable to tampering. AED accepted counterfeit software. No evidence of cryptographic integrity or authentication checks. No patient injuries or deaths reported. Related research paper on binary analysis at https://spqr.eecs.umich.edu/publications.php?q=hanna http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2390178
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protectedzoll medical corptransport defibrilator/monitor1992Defibrilator vulnerable to EMI from motorola radios used by EMT's. Can cause defibrillation by keying the radio. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=11488
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conflickerHut ext dr final assy-standard Urology suite2009A hard drive was replaced due to damage by the conflicker virus. All was then well.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=1513955
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databasePhillipsPhillips Medical Server2012A user could not zone alarms and a patient was killed. Phillips is currently reviewing their server.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2582571
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databaseAGFA Healthcare CorpImpax Database Server2012This server was imployed as a remote monitoring solution, the site shut down their t-1 broadband internet and then the server got much slower. Nobody was hurt.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2479571
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databasePhillipsPhillips Medical Server2012A patient died and there was no alarms. Phillips is investigating.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2410851
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databasePhillipsPhillips M3154 Large database server2012Pages were delayed up to 30 minutes. Phillips is determining whether this caused patient death.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2455324
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internetHosperia Costa RicaGemstar 7 therapy2012A patient was able to figure out using the internet how to unlock and reprogram their device in a suicide attempt.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2877089
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internetPicisanestesia manager2012Software would freeze, forms would be automatically filled in incorrectly, would not correctly communicate with server due to updating IP addresses and DNS servers.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2814143
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buffer overflowTolochenazDA+ C SERIES DR/IMPLANTABLE PULSE GENERATOR2012The implantable pulse generator underwent reset due to "pg event buffer overflow". I think the design of firmware lacks the protection mechanism of buffer overflow, such as the use of automatic protection at the language levelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2610595
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firmware corruptST. JUDE MEDICAL, INC.V-193 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM2006Device was accidentally placed near another one being updated, thus received a software update which corrupted ithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=660811
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software corruptADAC LABORATORIESPINNACLE3 RADIATION THERAPY PLANNING EQUIPMENT 1999Corrupt database / lock file allowed a user to overwrite CT data, while not properly invalidating dosage datahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=238127
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hackedMEDTRONIC 7427 Neurostimulator2008Patient thought their device was hacked (their neurotransmitter was doing weird things, turning on and off, etc), but it sounds unlikelyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1178928
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Segmentation faultZOLL LIFECOR CORPORATIONWEARABLE CARDIOVERTER DEFIBRILLATOR2012The monitor of the defribillator won't power on, and after further analysis, there was a segmentation fault found on the flash memory component. Nobody was hurt.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2799930
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segmentation faultINO THERAPEUTICAPPARATUS, NITRIC OXIDE DELIVERY2011Screen went blank while on a patient, and therapist immediately changed to another device for the patient. There was a high pitch alarm from the malfunctioned device, and it was later found to be an error caused by segmentation fault. Nobody was hurt in the event.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2357671
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Segmentation faultSTEALTHSTATION TREON TREATMENT GUIDANCE SYSTEMSTEREOTAXIC INSTRUMENT (HAW)
2011Patient information cant be read and system froze as information was written to bad memory location, resulting in segmentation fault. Nobody was hurt.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2045579
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Information security,MedtronicSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2012Devices right battery turned itself off when walked through library's security system, and the injury would have been more serious had the patient been driving. It might be the electromagnetic wave of the library security system that shut off the device.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2925153
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RebootPhilips medical systemPiic-ix2013Operational problem on the monitoring system such as system freeze, system lockup, spontaneous reboot, spontaneous activation of features such as alarm silence. Nobody was hurt, but the cause of the problems hasn't been identified. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2929894
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wirelessEXTERNAL MANUFACTURER

ZOOM2012The defibrillator malfunction is associated with the wireless communication malfunction. The product is now returned to manufacture for laboratory analysis, and I am not sure about what the exact problem was.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2913248
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ethernetMedtronicCARELINK PROGRAM W/TELEMETRY C2012The program is unable to load software due to a broken ethernet combo cardhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2788771
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rounding errorSiemansPHYSIOLOGICAL PATIENT MONITOR2002Drug calculator rounded up to the second decimal. Example given in report suggests potential over give more than 2X the dosage under certain conditionshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=440062
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buffer overflowMedtronicIMPLANTABLE PULSE GENERATOR2011Device had a POR event due to a "pg event buffer overflow". Cause was most likely a bit flip in the RAM that caused the firmware to get lost. "There is no way to know for certain"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2451660
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confickerFujiFilmCOMPUTED RADIOGRAPHY READER AND WORKSTATION2009Virus caused computer to freeze and not transfer images as expected and failed with 4 different patients. Multiple reboots fixed problem temporarily.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=1419194
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malwareCardiac ScienceAED G3 PLUS2010Device accepts counterfeight firmware that controls operation of devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=2390178
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windowsPhilipsSYSTEM, MONITOR, CARDIAC2013Since the install approximately 30 days ago, our system which covers about 150 telemetry patients has had a series of operational problems. Problems include: missing vital signs from screen, lock up of screen, spontaneous activation of features such as alarm silence, spontaneous display of ms windows screen, spontaneous lock up of system, spontaneous reboot of system.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2929894
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Computer software IssueSorin CRMSYMPHONY D 24502012In the histogram showing the distribution of atrio-ventricular versus the cardiac rate, negative values were displayed for some atrio-ventricular delays and frequencies below the programmed basic rate were displayed.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2834893
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Computer software IssueCanonCXDI CONTROL SOFTWARE NE VER. 2.00.0112012Problems include - Computer software issue; Image display error; Device displays error message. The customer reported as follows: after taking images, fatal error "f020200001" occurred and the control pc hung up. Then it was recovered by restarting, but erased and did not save the images taken immediately prior to this. It is possible that the image was retaken, resulting in unintended radiation exposure.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2865391
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Computer software IssueSORIN CRM S.R.L PARADYM RF DR 95502012Reportedly, during a follow-up performed on (b)(6) 2012, a windows error message was displayed to the user. Orchestra+ shut down and restart were requested. The follow-up could have been performed without further difficulties after reboot of the programmer.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2834923
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Computer software IssueSORIN CRM S.R.L REPLY SR2012During a regular f/u, physician checked episodes stored in pacemaker's memories. For one of them, it was not possible to display egm and markers chain corresponding to the episodes, and an error message was displayed by the programmer.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2834923
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Computer software IssueSORIN CRMOVATIO VR 62502012Reportedly, a known programmer software issue (therapies can be programmed in slowvt zone even when vt zone is off) has been corrected for other models, but is still observed with this ovatio icd upon interrogation with 2. 36j software version.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2833435
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Computer software IssueDATA INNOVATIONS LLCDATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE JQP CALCULATOR/DATE PROCESSING MODULE 2012 If filtering on connection name in the sm workspace, which can be accomplished by filtering on connection name or by limiting the user's access to connections via user security, the following issue will occur. When a sample has tests on multiple connections and the following actions are performed, the connection name filter will not be applied correctly when determining when tests to be performed by the action. Other filters used within the sm workspace will be respected. The following actions are affected: release, reject, manual download pending test, cancel, print barcode, send to host. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2759325
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Computer software IssueNEWPORT MEDICAL INSTRUMENTS, INCE360 VENTILATOR2012It was reported that a rom (read only memory) failure occurred during testing of the ventilator. It was reported that the ventilator then shut downhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2700544
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Computer software IssueMEDTRONIC NAVIGATION INC.STEALTHSTATION S7 SYSTEM2012during an epilepsy electrode placement case using synergy cranial software version 2. 1, the software displayed unusual behavior. While in the biopsy procedure, the user merged a t1 and a t2 mri data set and created three plans. Each time the user clicked on a plan, a duplicate plan was automatically created. When the user clicked on plan #1, then plan #4 would create and be a duplicate of plan #1. It was also noted that if the "re-set entry" button was selected, it moved the target instead of the entry point and if the "re-set target" button was selected, it moved the entry point instead of the target.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2615862
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Computer software IssueMEDTRONIC NAVIGATION INC.FUSION NAVIGATION SYSTEM2012Report that the site received a "communication error" while in the navigate task in an ent procedure. After a hard-boot of the system the surgeon completed the surgery with the use of the fusion navigation system.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2588394
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Computer software IssueMEDTRONIC S.AINSYNC SENTRY
- IMPLANTABLE PACEMAKER/CARDIO/DEFIB
2012It was reported that the atrial lead had increased thresholds. The atrial lead was removed and replaced. It was also reported that the right ventricular lead had sensing difficulty, oversensing , and an increase in lead impedance. The right ventricular lead was removed and replaced. Diagnosis revealed that this was a RAM parity error.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2537132
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Computer software IssueMEDTRONIC, INC.CARELINK
PROGRAMMER
2012It was reported, the programmer will not boot. The service disk was attempted, with no successhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2534723
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Computer software IssueMEDTRONIC, INCCARELINK PROGRAM W/TELEMETRY C2012It was reported the programmer is extremely slow to boot up, and it occasionally freezes up during interrogations. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2534725
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Computer software IssueMEDTRONIC S.ADA+ T SERIES DR
IMPLANTABLE PULSE GENERATOR
2012It was reported that there was an error notification on the device possibly due to a flipped bit. A manual guided reset procedure will be performed. The device remains in use.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2529801
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Computer software IssueMEDTRONIC MED REL, INCREVO MRI SURESCAN2012It was reported that the device experienced a power on reset possibly due to a critical ram error. It was also reported that the patient had magnetic resonance imaging with surescan programming prior to the reset.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2530793
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Computer Software IssueMEDTRONIC MED REL, INCMAXIMO VR- IMPLANTABLE PACEMAKER/CARDIAC/DEFIB2012It was reported the device displayed a message of "data invalid" and that lead trend data was not available due to a memory error or bit flip. The device remains in use. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2531849
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Computer operating system issueBAUSCH & LOMB, INCSTELLARIS PC VISION ENHANCEMENT SYSTEM

2012A report was received from a user facility in (b)(6) stating "when we brought up the keypad for the timer we only got half of the keypad showing on the screen and then a windows "communication" error box appeared. The system then went to a white screen with the b&l logo for a moment and then rebooted. We tried to prime another cassette and that failed. It took approx 5 minutes to restart the system. In that time the pt developed a choroidal hemorrhage and the surgery was then aborted. ".http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2364682
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Computer operating system issueTERUMO CARDIOVASCULAR SYSTEMS CORPTERUMO ADVANCED PERFUSION SYSTEM 1
CENTRAL CONTROL MONITOR
2012After use of the device for a cardiopulmonary bypass procedure, the user reported that the central control monitor froze up. The device was not changed out and the user finished manuallyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2257819
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Computer operating system issueABBOTT MANUFACTURING, INCI2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER 2012The customer states that error code 9077, unable to communicate to sample handler or processing module, was generated by the architect i2000sr analyzer. An abbott field service engineer (fse) visited the customer site. The customer informed the fse that when he came into the lab, the analyzer's module 2 was offline. The breaker was tripped and when the breaker was turned back on, the customer saw sparks at the back of the analyzer accompanied by smoke. The fse could also see that one of the power supply cards was burnt. The fse inspected the analyzer for any further evidence of the analyzer short-circuiting but found none. The fse replaced the power supply card and subsequent instrument operation was acceptable. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1884309
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Computer operating system issueABBOTT DIABETES CARE INC, USAFREESTYLE -BLOOD GLUCOSE MONITORING SYSTEM2012The customer reported an issue with their meter which suggests the memory overwrite malfunction has occurred. The product has been requested for investigation.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1788865
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Computer operating system issueMEDTRONIC NEUROMODULATIONSYNCHROMED EL2011A pump memory error displayed. It took 30 minutes to update the pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2040924
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Computer operating system issueWELCH ALLYN PROTOCOL, INCACUITY CENTRAL MONITORING

2009The customer reported that their acuity central station rebooted for unknown reasons. The acuity system successfully rebooted on its own and functioned normally afterwards. The result is that the customer lost the ability to monitor patients from the central location for approximately 5 minutes. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1570921
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Computer operating system issueGE OEC MEDICAL SYSTEMS INC6800
- FLUOROSCOPIC X-RAY
2009The customer reported that there were communication errors and then the system would not boot. The ge service rep reseated the pcbs, replaced the cmos battery and reloaded the softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1909071
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wireless firmwarePhilipsM3001 Multi-measurement monitor module2010ECG stops working due to nearby interference from a cell phone, wireless network card, or medical humidifier.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1679255
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wireless firmwarePhilipsX2 Patient Monitor2011Similar problem as above, but with the X2. Nearby laptops with wireless cards caused ECG alarms to incorrectly go off (false alarm). Reducing wireless transmit power solved the issue, Philips also released a firmware update for the monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2154693
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checksum updateBeckman Coulter LH 750 HEMATOLOGY ANALYZER2008Checksum feature on a barcode scanner was disabled, thus results were matched to the wrong patient when a barcode was misreadhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2324134
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firmware Hospera SYMBIQ DUAL CHANNEL PUMP2012Device alarmed and gave a software error message which could not be replicated. Device then passed all testing.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=2934599
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communication errorNEWPORT MEDICAL INSTRUMENTS, INCE360 VENTILATOR2013No communication error reported, customer switched from that ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2922038
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communication errorMEDTRONIC MED REL MEDTRONRestore2013Patient not able to communicate with implantable neurosimulator via recharger or programmer. Communication in process screen never changed. Device eventually caused the return of symptoms.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2893583
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communication errorST. JUDE MEDICAL - NEUROMeon mini2013Patient could not communicate with scs using programmer. Replacement programmer did not resolve issue. Error has now cause the return of original symptons.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2929419
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frozeABBOTT MEDICAL OPTICSWHITESTAR SIGNATURE SYSTEM2013Device hung when changing modes. Repair was attemped by changing PCBs, delay of 10-15 minutes, no injury reportedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2904888
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firewallSUPERDIMENSION INC.SUPERDIMENSION INREACH SYSTEM2011The firewall is turned on during the anti-virus updating, which disrupted communication with the lss and the ipchttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2224751
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frozeimpact instrumentationimpact emv portable ventilator2013Screen froze and ventilator was unresponsive. No injury reported and not replicatable. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2910389
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antivirusPHILIPS XCELERA2009Several computers in the hospital got infected with a computer virus. Philips medical systems believes they are not responsible for the installation or maintenance of antivirus software or for the integrity of the xcelera system infected with a computer virus.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1568388
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incorrectmedtronic puetro ricoPARADIGM REAL-TIME REVEL INSULIN IN2013Emergency room due to high blood pressure. Device failed high press test and was replaced. Device was for some reason misconfigured.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2930671
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incorrectANIMAS CORPORATIONONETOUCH PING INSULIN PUMP2013Device resets time on battery change which affects the therapy. Bg not steady due to this error. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2938030
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antivirusSIEMENS MEDICAL SOLUTIONS USA, INC. E-CAM2005A sasser virus infected 2 files in the ms windows 2000 operating system.The virus comes from the hospital's computer networkhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=602873
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engineeringGUIDANT CRM CLONMELe1102013Alarm on a incorrect projected longevity, device replacedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2929075
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PWMPHYSIO-CONTROL, INC.LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER2008The device blows a fuse. The reason is the malfunction of the PWM controller of the systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1282285
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overwrite
ABBOTT DIABETES CARE INC
FREESTYLE2007The meter experienced a memory overwirte problem. I think the reason is because it's not designed with memory protection mechanismhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1788865
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software errorHOSPIRA COSTA RICA LTD.SINGLE CHANNEL 802013Device alarmed a white screen error on reboot. No injuries reported.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2915626
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whitescreenHOSPIRA COSTA RICA LTD.YMBIQ TUBING SINGLE CHANNE 80FRN 2013Device reported message "Processer Malfunction: clamp the immediatly". Upon emergency reboot device was reprogramed, although no specific programming parameters were providedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2904115
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computer failureBLOOD BANK COMPUTER SYSTEMBBCS MOBILE APPLICATION2010Data was lost when merging collected data from a mobile application to the main servers.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1861240
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cacheVARIAN MEDICAL SYSTEMS, INC.ECLIPSE TREATMENT PLANNING SYSTEM2012This issue is caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning (b)(4). When the user changes the field energy, the memory cache anomaly may result in the use of the previously selected field energy instead of the intended field energyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2748723
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computer failure
CYBERONICS, INC.
MODEL 2502010Would freeze when software would load, determined to be a problem with a malfunctioning touchscreen, fixed.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1832113
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computer failureZOLL LIFECOR CORPORATIONWCD 40002012Device would fail to boot due to flash memory failure.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2768680
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computer failureHILL ROM SERVICES, INCNURSE COMMUNICATIONS MODULE2012Monitor would not stop alarming, cause determined to be a corrupt file on the master station computer, the affected computer was configured to be a slavehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2749417
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computer failure SYNCARDIA SYSTEMS SYNCARDIA COMPANION 2 DRIVER, CIRCULATORY ASSIST DEVICE 2012Syncardia logo would persist when driver was turned on. Reboot was then necessary.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2722116
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initializationSYMPHONY D 2450SYMPHONY DR 25502012When the pacemaker is in standby mode and the re-initialization is not completed first, the device interrogation could not be completedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2750178
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bugCANON, INC.CXDI-70C WIRELESS2012 The cause of the problem is a bug in the firmware. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2897102
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allocationCOVIDIEN LP (BARRX)HALOFLEX (115V) GENERATOR2012There is a memory allocation issue at power on self-test.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2736667
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