BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 19838867 · Received July 26, 2024

    Report

    Report Number
    3003521780-2024-00797
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Report Date
    June 28, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020239
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. ALTHOUGH REQUESTED, THE AED AND BATTERY PACK HAVE NOT BEEN RETURNED 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

    A CUSTOMER STATED THAT THE BATTERY EXPIRED EARLIER THAN THE EXPIRATION DATE. BATTERY EXPIRATION DATE IS ON 29-02-2028. THE UNIT HAS A WARNING OF BATTERY LOW. THE UNIT IS SOFTWARE VERSION 2.9 AND IT WAS UNABLE TO RETRIEVE DATA FILES. WHEN INSERTING THE CARD TO RETRIEVE DATA, IT FOUND "DATA CARD DEFECT / ERROR". THEY DID NOT REPORT THAT THIS EVENT OCCURRED DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529662 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-2300 10815098020239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown