BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 19051297 · Received April 5, 2024

    Report

    Report Number
    3003521780-2024-00263
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Report Date
    March 8, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020079
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MDR SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR AED VOLUME IS LOW. THEY DID NOT REPORT THAT THIS OCCURED DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70621 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-100 10815098020079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown