BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FRX

    MDR report key: 11810816 · Received May 12, 2021

    Report

    Report Number
    3030677-2021-11435
    Event Type
    Death
    Date Received
    May 12, 2021
    Date of Event
    May 6, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER IS REPORTING THE DEVICE DID NOT POWER ON WHEN IT WAS RETRIEVED FOR A PATIENT USE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711591 HEARTSTART FRX AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death