BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 20793155 · Received November 27, 2024

    Report

    Report Number
    3003521780-2024-01324
    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
    OR, 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 THEIR AED IS FLASHING RED AND PROMPTING A "REPLACE BATTERY PACK NOW WARNING. THEY REPORTED THIS DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383654 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100A 10815098020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown