BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1273585 · Received December 18, 2008

    Report

    Report Number
    3003521780-2008-00029
    Event Type
    Death
    Date Received
    December 18, 2008
    Date of Event
    September 12, 2008
    Report Date
    November 12, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Removal / Correction Number
    Z-0580-2007/ Z-0581-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE ELECTRONIC HISTORY FILE FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. SUMMARY: BASED ON THE ELECTRONIC HISTORY FILE EVALUATION, THE SOFTWARE INCORRECTLY CLEARED A LOW BATTERY WARNING, AS ADDRESSED IN RECALL. ALSO, SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS.

    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. THE DEVICE'S ELECTRONIC HISTORY FILE WAS RECEIVED, AND REVIEW OF THE FILE INDICATED THAT FOR AN UNREPORTED USE IN 2008, A SHOCK WAS REQUIRED AND THEN CANCELLED, REPORTING A REPLACE BATTERY MESSAGE BEFORE POWERING OFF. IT WAS REPORTED THAT THE PATIENT INVOLVED IN THE 2008, INCIDENT 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 80 YR Death