BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 19863103 · Received July 30, 2024

    Report

    Report Number
    3030677-2024-02689
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Report Date
    October 24, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (INITIALLY CONSIDERED AS SPLIT) IS NOW BEING CONSIDERED A DUPLICATE OF (B)(4). AS SUCH, FILE (5003788) WILL BE CLOSED AS A DUPLICATE AND ALL RELEVANT INFORMATION PERTAINING TO THE INVESTIGATION ASSOCIATED WITH THIS EVENT WILL BE HOUSED IN THIS (B)(4).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244210 HEARTSTART FRX AED MKJ PHILIPS NORTH AMERICA LLC 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown