BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 23257984 · Received October 9, 2025

    Report

    Report Number
    3030677-2025-002277
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Report Date
    October 29, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    NSA
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING CONCLUSION CODE GRID. ALSO SEE MFR REPORT #3030677-2025-001627 WHICH CONTAINS INFORMATION ASSOCIATED WITH THIS SAME EVENT.

    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
    2046056 HEARTSTART AED NSA PHILIPS NORTH AMERICA LLC HEARTSTART HS1 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown