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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number M3535A
Device Problem No Display/Image (1183)
Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 03/11/2019
Event Type  malfunction  
Event Description
Patient was unresponsive, pulseless and not breathing adequately. Cpr was in progress and when i went to put the defibrillator pads on the patient, the monitor would not display a heart rhythm. Csi team notified. Biomed notified. Leadership notified.
 
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Brand NameHEARTSTART MRX
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
MDR Report Key8691327
MDR Text Key147777805
Report Number8691327
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2019
Event Location Hospital
Date Report to Manufacturer06/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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