BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20041699 · Received August 22, 2024

    Report

    Report Number
    3030677-2024-03044
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Report Date
    November 19, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL "DATE RECEIVED BY MANUFACTURER" ON EMDR 5102701 WITH MFR REPORT NUMBER 3030677-2024-03044 SHOULD BE 07AUGUST2024.

    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
    2070897 HS1 (W B) ONSITE DEFIB, US ENGLISH,EXCHG AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown