BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HATZALAH

    MDR report key: 22418736 · Received July 7, 2025

    Report

    Report Number
    3003521780-2025-00658
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Report Date
    July 7, 2025
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020710
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS AED NOR ITS ELECTRONIC LOG FILES WERE RETURNED AND THUS THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR AED WILL NOT SPEAK. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204234 HATZALAH AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100H 10815098020710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown