BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1980138 · Received February 1, 2011

    Report

    Report Number
    3003521780-2011-00002
    Event Type
    Death
    Date Received
    February 1, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 3, 2011
    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. THE CONDITIONS IDENTIFIED DURING THE INVESTIGATION WERE ADDRESSED IN RECALL #Z-0580-2007 AND #Z-0581-2007. ALSO, SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS. AN UPGRADE KIT WAS SENT TO THE END CUSTOMER TO ADDRESS THE CONDITION IDENTIFIED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT A DEVICE DID NOT POWER ON DURING A RESCUE ATTEMPT. ELECTRONIC USAGE HISTORY FOR THE DEVICE WAS RECEIVED AND REVIEWED. IT SHOWED THAT ON (B)(6) 2011, THE DEVICE DID NOT POWER ON, INITIALLY. THE DEVICE WAS THEN POWERED ON A SECOND AND THIRD TIME. IN BOTH CASES, THE DEVICE ANALYZED, CHARGED AND THEN CANCELED THE SHOCK AND POWERED OFF, REPORTING A LOW BATTERY CONDITION.

    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 Death