BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 21998079 · Received May 9, 2025

    Report

    Report Number
    3003521780-2025-00388
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Report Date
    April 10, 2025
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020000
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TROUBLESHOOTING OF THE AED WITH THE CUSTOMER IDENTIFIED THAT THE AED'S BATTERY PACK WAS EXPIRED WITH A LABELED EXPIRATION DATE OF 03/2030. THIS AED NOR BATTERY PACK WERE RETURNED AND THUS THE ROOT CAUSE COULD NOT BE DETERMINED. TROUBLESHOOTING OF THE AED WITH THE CUSTOMER IDENTIFIED THAT THE AED IS FUNCTIONING AS DESIGNED AND CAN STAY IN SERVICE.

    Additional Manufacturer Narrative · 0

    UPON RETURN, THE DEVICE UNDERWENT BENCH TESTING, IT WAS CONFIRMED THAT THE BATTERY PACK COULD NOT BE SECURELY LATCHED INTO THE BATTERY WELL. THE ISSUE WAS CAUSED BY BROKEN BATTERY LATCH, WHICH ARE INTENDED TO ASSIST IN SECURING THE BATTERY IN PLACE. DESPITE THE DAMAGED LATCH, THE DEVICE IS ABLE TO FUNCTION WHEN THE BATTERY IS MANUALLY HELD IN POSITION. THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR BATTERY PACK WILL NOT STAY LATCHED IN THEIR AED. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131052 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100A 10815098020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown