BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 22485342 · Received July 11, 2025

    Report

    Report Number
    3030677-2025-001630
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Report Date
    July 15, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REPORTED IN ERROR AND WILL BE CONSIDERED A DUPLICATE OF PR (B)(4). DEVICE INVESTIGATION IS PENDING THE RETURN OF THE DEVICE. DEVICE INVESTIGATION WILL TAKE PLACE ON PR (B)(4) WITH MDR # 3030677-2025-001649.

    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
    653084 HEARTSTART AED NSA PHILIPS NORTH AMERICA LLC HEARTSTART HS1 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown