BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 21973026 · Received May 6, 2025

    Report

    Report Number
    3003521780-2025-00432
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Report Date
    April 7, 2025
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020079
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THAT THEIR AED POWERS ON AND INITIATES A SELF-TEST BUT SHUTS DOWN BEFORE COMPLETING THE TEST. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423104 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-120E 10815098020079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown