BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 12107880 · Received July 2, 2021

    Report

    Report Number
    3030677-2021-12662
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 9, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS, THAT THE DEVICE FAILS DEFIBRILLATION TEST. THERE WAS NO PATIENT INVOLVEMENT. THE BENCH TECHNICIAN EVALUATED THE DEVICE. CONFIRMED, THE FAILING DEFIBRILLATION TEST. THE DEVICE NEEDS A HIGH VOLTAGE CAPACITATOR AND A THERAPY PCA. THE THERAPY BOARD WAS RETURNED. AND HAD FAILURE ANALYSIS PERFORMED ON IT. THE REPORTED ALLEGATION ABOUT THE "FAILING DEFIB TEST " WAS NOT VERIFIED OR DUPLICATED, DURING LAB TESTS. THE THERAPY PCA PASSED ALL TESTS, DURING OPERATIONAL CHECK. AND PERFORMED AS EXPECTED. THEREFORE, THERE IS NO FAULT FOUND (NFF) WITH THIS THERAPY BOARD IT WAS DETERMINED, THAT THE THERAPY PCA AND A HIGH VOLTAGE CAPACITOR REQUIRE REPLACEMENT. WE ARE UNABLE TO DETERMINE, THE ROOT CAUSE OF THE EVENT AS MULTIPLE PARTS WERE REQUIRED FOR REPLACEMENT. THE PARTS WERE REPLACED. AND THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS DEFIBRILLATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003570 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown