BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX DEFIBRILLATOR

    MDR report key: 12075579 · Received June 28, 2021

    Report

    Report Number
    3030677-2021-12530
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970682 HEARTSTART FRX DEFIBRILLATOR AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown