BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 19567642 · Received June 19, 2024

    Report

    Report Number
    3003521780-2024-00634
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Report Date
    May 20, 2024
    Manufacturer
    DEFIBTECH LLC
    Product Code
    MKJ
    UDI-DI
    10815098020222
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING THE COMPLAINT HAS NOT BEEN PROVIDED AND THE CAUSE OF THE COMPLAINT IS NOT KNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MDR SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR AED WILL NOT POWER ON AND DISPLAYED SERVICE CODE "AED ERROR OR WARNING". THE REPORTED EVENT DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673667 LIFELINE AUTOMATED EXTERNAL DEFIBRILATOR MKJ DEFIBTECH LLC DDU-2300 10815098020222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown