BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1211372 · Received October 22, 2008

    Report

    Report Number
    3003521780-2008-00020
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS - BASED ON THE EVALUATION OF THE DEVICE AND AVAILABLE INFO, NO CONCLUSION CAN BE MADE AT THIS TIME. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ABORTED SHOCKS WHEN HOOKED UP TO A SIMULATOR. THERE WAS NO PT INVOLVEMENT.

    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