BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE AED

    MDR report key: 2881530 · Received December 18, 2012

    Report

    Report Number
    3003521780-2012-00007
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS DUE TO A FALSE FAILURE OF THE SOFTWARE CHECK DUE TO INTERFERENCE DURING CHARGING. A REPORT OF CORRECTION FOR THIS ISSUE HAS BEEN FILED WITH FDA. THE DEVICE WAS REMOVED FROM THE FIELD TO ASSIST WITH THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT AN AED WAS USED DURING A RESCUE ATTEMPT AND THAT THE AED REPORTED A SERVICE CODE. THE PATIENT WAS TRANSFERRED TO A SECOND DEFIBRILLATOR. PATIENT OUTCOME IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening