BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 1265709 · Received December 16, 2008

    Report

    Report Number
    3003521780-2008-00026
    Event Type
    Malfunction
    Date Received
    December 16, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 17, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: TESTING PERFORMED HAS BEEN UNABLE TO REPRODUCE ERROR MODE REPORTED. THE INVESTIGATION REMAINS OPEN. RESULTS: THE ACTUAL DEVICE HAS BEEN EVALUATED. TESTING PERFORMED HAS BEEN UNABLE TO REPRODUCE ERROR MODE REPORTED. 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-100E IT NA

    Patients

    Seq Age Sex Outcome Treatment
    1