BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS1 DEFIBRILLATOR, FRENCH, EXCHANGE

    MDR report key: 16414536 · Received February 21, 2023

    Report

    Report Number
    3030677-2023-00764
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED 510K FROM P160028 TO P160029.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408531 HS1 DEFIBRILLATOR, FRENCH, EXCHANGE AED MKJ PHILIPS NORTH AMERICA LLC M5066-RFABF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown