BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS1 DEFIBRILLATOR, SPANISH, EXCHANGE

    MDR report key: 11611982 · Received April 4, 2021

    Report

    Report Number
    3030677-2021-10658
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838049123
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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
    509370 HS1 DEFIBRILLATOR, SPANISH, EXCHANGE AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838049123

    Patients

    Seq Age Sex Outcome Treatment
    1