BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX DEFIBRILLATOR

    MDR report key: 14518702 · Received May 26, 2022

    Report

    Report Number
    3030677-2022-02741
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED PMA TO P180028 AND MODEL NUMBER TO 861304.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604503 HEARTSTART FRX DEFIBRILLATOR AED MKJ PHILIPS NORTH AMERICA LLC 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown