BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART FRX

    MDR report key: 20319659 · Received September 27, 2024

    Report

    Report Number
    3030677-2024-03466
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Report Date
    April 11, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO COMPONENT CODE GRID. ON EMDR 5232299 THE "DATE RECEIVED BY MANUFACTURER" SHOULD BE 09/18/2024.

    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
    1371657 PHILIPS HEARTSTART FRX AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown