BEUDAMED
    FDA Adverse Event Summary report: N

    LIFELINE AED

    MDR report key: 2864295 · Received December 5, 2012

    Report

    Report Number
    3003521780-2012-00006
    Date Received
    December 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT HAS BEEN REQUESTED TO BE RETURNED TO ASSIST WITH THE INVESTIGATION; HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PRESSING THE ON BUTTON, THE AED POWERED OFF, AUTOMATICALLY, AFTER A FEW SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

    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