BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 25317241 · Received May 28, 2026

    Report

    Report Number
    3030677-2026-100607
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    NSA
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE WOULD NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163944 HEARTSTART OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR NSA PHILIPS NORTH AMERICA LLC HEARTSTART HS1 11725 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1