BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 9284470 · Received November 6, 2019

    Report

    Report Number
    1218950-2019-08441
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Report Date
    October 31, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A THERAPY DELIVERY TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT. ONE POWER PCA WAS RETURNED TO FAILURE ANALYSIS FOR EVALUATION. THE PCA PASSED ALL THE TESTS. NO FAULT FOUND (NFF) WITH THIS POWER BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A THERAPY DELIVERY TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077654 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1