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

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.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• 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 Key: 6254484
• MDR Text Key: 64882896
• Report Number: 1218950-2017-00392
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR