BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRX DEFIBRILLATOR, ITALIAN, EXCHANGE

    MDR report key: 13771629 · Received March 15, 2022

    Report

    Report Number
    3030677-2022-01563
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    510K CORRECTED TO P180028.

    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
    15906 FRX DEFIBRILLATOR, ITALIAN, EXCHANGE AED MKJ PHILIPS NORTH AMERICA LLC 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown