BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1353796 · Received March 30, 2009

    Report

    Report Number
    3003521780-2009-00008
    Event Type
    Death
    Date Received
    March 30, 2009
    Date of Event
    February 14, 2009
    Report Date
    February 27, 2009
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS - THE ACTUAL DEVICE HAS BEEN EVALUATED. EVALUATION RESULT, ERROR HANDLING FAULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS REPORTING A SERVICE MESSAGE AND THAT THE ERROR DID NOT OCCUR DURING PATIENT USE. IN 2009, THE DEVICE'S ELECTRONIC HISTORY FILE WAS RECEIVED AND REVIEW OF THE FILE INDICATED THAT FOR A USE THIRTEEN DAYS PRIOR, 2 SHOCKS WERE REQUIRED AND THAT EACH WAS ABORTED, REPORTING A SERVICE MESSAGE. FOLLOW-UP WITH THE END CUSTOMER INDICATED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR, HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT SURVIVE.

    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 86 YR Death