BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART HOME

    MDR report key: 10247933 · Received July 8, 2020

    Report

    Report Number
    3030677-2020-01069
    Event Type
    Injury
    Date Received
    July 8, 2020
    Report Date
    July 7, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    K040904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER IS STATING THAT DURING A PATIENT EVENT, WHEN THERAPY WAS ATTEMPTED TO BE DELIVERED THE DEVICE DID NO INSTRUCT TO SHOCK THE PATIENT. THE PATIENT WAS RESUSCITATED BUT FOUND TO BE BRAIN DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709356 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1