BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1371895 · Received February 16, 2009

    Report

    Report Number
    3003521780-2009-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 15, 2009
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE CANCELLED A SHOCK WHEN CONNECTED 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