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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problems Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Patient information was not available.
 
Event Description
It was reported to philips that a paramedic crew on a cardiac arrest encountered a monitor failure.The crew was able to deliver one defibrillation and, after the shock, the monitor prompted ¿apply pads¿.The crew placed new pads and attempted to trouble shoot, but was unable to deliver any more defibrillations.Another crew took over patient care and transported the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment and will be considered a serious injury.Additional details have been requested.
 
Event Description
It was reported to philips that a paramedic crew on a cardiac arrest encountered a monitor failure.The crew was able to deliver one defibrillation and, after the shock, the monitor prompted ¿apply pads¿.The crew placed new pads and attempted to trouble shoot, but was unable to deliver any more defibrillations.Another crew took over patient care and transported the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment and will be considered a serious injury.A philips clinician reviewed the event file which showed the device was powered on into manual mode.A patient rhythm was established via pads and evidence of chest compressions was observed.Two brief pads off messages were noted, at 0:17 elapsed time (et) and 5:46 et, lasting approximately two seconds each time before the pads waveform was re-established.At 11:52 et, a shock of 200j was delivered which did not convert the patient rhythm.After the shock was delivered there was a pads off condition as evidenced by a dashed line until 14:34 et when a leads ecg waveform was established.The pads off condition corresponds to the time period where users were attempting to troubleshoot the pads off condition and associated on-screen message of ¿apply pads¿.The users were unable to re-establish a pads ecg waveform.The patient was transferred to hospital care.A philips field service engineer evaluated the device and determined the issue was caused by the therapy cable.The therapy cable was returned to philips.The philips failure analysis lab tested the cable and determined that the sternum hv pin contact internal line had an open circuit, which caused the shocks to fail.The date code on the therapy cable was 01/2014.This therapy cable failure is consistent with ordinary wear and tear for a therapy cable that continues to be used past the three year service life of the cable.The heartstart mrx instructions for use (publication 453564307761, page 286) states: "the service life of your therapy cables is up to three years.To maintain reliable performance and reduce the possibility of failure during patient use, replace them every three years from the time they were initially placed into service or if they fail inspection criteria." following replacement of the therapy cable, the defibrillator passed all performance assurance testing.The pads off condition and inability to deliver more than one shock resulted from the therapy cable open circuit.This therapy cable was in use for greater than its specified and documented life expectancy.
 
Manufacturer Narrative
H.10.Patient information was requested but unknown.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
HEARTSTART MRX -EMS DEFIBRILLATOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10236071
MDR Text Key197676677
Report Number1218950-2020-03891
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3536A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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