BEUDAMED
    FDA Adverse Event Death Summary report: N

    HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG

    MDR report key: 14360982 · Received May 11, 2022

    Report

    Report Number
    3030677-2022-02520
    Event Type
    Death
    Date Received
    May 11, 2022
    Date of Event
    May 6, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING A PATIENT USE, THE DEVICE DID NOT FUNCTION AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915037 HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death