BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 6656267 · Received June 21, 2017

    Report

    Report Number
    1218950-2017-04168
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Report Date
    June 2, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVERTER PCA AND HIF PCA WERE REPLACED AND THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS PLACED BACK IN SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A "BURNED INVERTER PCA". THERE WAS NO REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439403 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1