BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1040928 · Received May 9, 2008

    Report

    Report Number
    3003521780-2008-00004
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    June 24, 2007
    Report Date
    May 2, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    PMA / PMN Number
    K013896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE ACTUAL DEVICE INDICATES THAT THE DEVICE WAS DAMAGED IN THE FIELD, CAUSING COMPONENTS TO BE SHEARED FROM THE INTERNAL CIRCUIT BOARD. REVIEW OF THE ELECTRONIC HISTORY FILE INDICATES THAT SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS PRIOR TO THE INCIDENT AND FOR APPROXIMATELY TEN MONTHS AFTER THE FIRST DEPLOYMENT INCIDENT. SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS.

    Description of Event or Problem · 1

    IN 2008, THERE WAS AN END CUSTOMER REPORT THAT, NOT DURING PATIENT USE, A DEVICE WAS REPORTING A SERVICE REQUIRED PROMPT. A WEEK LATER, REVIEW OF THE ACTUAL DEVICE AND ITS ELECTRONIC HISTORY FILE DETERMINED THAT DURING A DEPLOYMENT OF THE DEVICE TWO MONTHS LATER THE DEVICE ADVISED A SHOCK, REPORTED A SERVICE REQUIRED MESSAGE AND CANCELED THE SHOCK. FIVE ADDITIONAL RESCUE ATTEMPTS WITH SIMILAR OUTCOMES WERE LOGGED IN THE ELECTRONIC HISTORY FILE. TO DATE, NO FURTHER INCIDENT DETAILS OR PATIENT OUTCOMES 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