BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 20793048 · Received November 27, 2024

    Report

    Report Number
    3003521780-2024-01326
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Report Date
    October 29, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020000
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE AED IS FUNCTIONING AS DESIGNED AND CAN REMAIN IN SERVICE. HOWEVER, WHEN TESTED WITH A REPLACEMENT BATTERY PACK, A SERVICE CODE WAS IDENTIFIED. IF LEFT UNADDRESSED, THIS ISSUE COULD HAVE LED TO THE GRADUAL DEPLETION OF THE BATTERY PACK OVER TIME. AS A FOLLOW-UP, PROPER MAINTENANCE PROCEDURES FOR THE DEVICE WERE REVIEWED WITH THE CUSTOMER TO ENSURE ONGOING RELIABILITY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEIR AED'S ASI IS BLANK, AND THE AED WILL NOT POWER ON. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831926 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100A 10815098020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown