BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE, AED

    MDR report key: 1253109 · Received December 5, 2008

    Report

    Report Number
    3003521780-2008-00025
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - THE ELECTRONIC HISTORY FILES FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE EVALUATED. THE ACTUAL DEVICE HAS BEEN REQUESTED FOR FURTHER EVALUATION, HOWEVER, TO DATE, IT HAS NOT BEEN RETURNED. RESULTS CODE - BASED ON THE REVIEW OF AVAILABLE INFORMATION, NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT A DEVICE WAS REPORTING A SERVICE MESSAGE, AND THAT THE ERROR DID NOT OCCUR DURING PATIENT USE. THE DEVICE'S ELECTRONIC HISTORY FILE WAS RECEIVED AND REVIEW OF THE FILE INDICATED, THAT FOR A USE ON THREE MONTHS EARLIER, A SHOCK WAS REQUIRED AND THEN ABORTED, REPORTING A SERVICE REQUIRED MESSAGE. NO PATIENT DETAILS OR OUTCOME ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE, AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening