BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART ONSITE

    MDR report key: 11776798 · Received May 5, 2021

    Report

    Report Number
    3030677-2021-11311
    Event Type
    Death
    Date Received
    May 5, 2021
    Date of Event
    May 3, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATENT USED CASE (PRODUCT SPECIALIST ). CUSTOMER WAS USING THE HS1 ON A PATIENT AND THE DEVICE DID NOT ADMINISTER A SHOCK, SN (B)(4), BATTERY INSTALL BEFORE DATE: 2023-12, LOT 76303P. PADS EXP DATE: 08-2021, LOT Y020719-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672634 HEARTSTART ONSITE AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death