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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 06/25/2020
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted after philips obtains more information concerning this event.
 
Event Description
It was reported to philips the device did not shock during ventricular defibrillation.The patient was experiencing respiratory cardiac arrest and the patient died.Additional details have been requested.
 
Manufacturer Narrative
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.
 
Event Description
It was reported to philips the device did not shock during ventricular defibrillation.The patient experienced respiratory cardiac arrest and the clinician massaged and ventilated the patient, and defibrillator pads were attached.The clinician could not see the tracing on the screen so the connection was checked.The clinician then switched to a different defibrillator using an adhesive pad but they were now seeing a non shockable rhythm of asystole.The patient died of cardiac arrest by asystole, therefore no shock was necessary.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10257842
MDR Text Key198369776
Report Number1218950-2020-03996
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 foreign,user facility
Type of Report Initial,Followup
Report Date 07/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age84 YR
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