BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART FRX

    MDR report key: 24431595 · Received February 24, 2026

    Report

    Report Number
    3030677-2026-100236
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Report Date
    May 7, 2026
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL "DATE RECEIVED BY MANUFACTURER" ON EMDR 7021025 WITH MFR REPORT NUMBER 3030677-2026-100236 SHOULD BE 12FEB2026.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531545 PHILIPS HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS NORTH AMERICA LLC HEARTSTART FRX 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown