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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEART START XL DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Invalid Sensing (2293)
Patient Problems Death (1802); Loss Of Pulse (2562)
Event Date 01/06/2017
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that when in aed mode the device advised a shock to a patient that appeared to be in a pulseless electrical activity (pea) rhythm. The operator of the device delivered the shock per the device's instruction. The user's concern is why did the defibrillator advise a shock when the rhythm appeared to be pea. The involved patient died.
 
Manufacturer Narrative
The device was evaluated by the customer clinical engineer department. The device correctly identified and responded to simulated rhythms. The device passed all performed tests. The electronic event file from this event was provided for review and dates (b)(6) 2017. The device was powered on into the aed mode, pads were placed and the first shock advisory decision was a ¿no shock advised¿ decision. The next analysis period started at 3:26 elapsed time (et) and this period included large deflections at a rate of approximately 170/minute. The algorithm advised a shock for this presenting waveform. These deflections stopped and the shock was delivered by the users. There were two subsequent shock advisory decisions at 4:39 et and at 6:12 et. This event is consistent with the delivery of chest compressions during the analysis period for the second shock advisory decision. The customer was provided information regarding the devices shock advisory algorithm. This is consistent with a use issue in which the users continued to perform chest compressions during the analysis phase. The shock advisory algorithm performed as designed.
 
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Brand NameHEART START XL
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6254484
MDR Text Key64882896
Report Number1218950-2017-00392
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM4735A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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