BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 3202012 · Received June 27, 2013

    Report

    Report Number
    3003521780-2013-00011
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE INVESTIGATION REMAINS OPEN AND NO CONCLUSIONS CAN BE MADE AT THIS TIME. BASED ON THE OUTCOME OF THE INVESTIGATION, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT DURING A MANUAL SELF-TEST OF THE DEVICE, THE END CUSTOMER PRESSED THE SHOCK BUTTON, WHEN PROMPTED, THE UNIT ANNOUNCED A SERVICE CODE AND IMMEDIATELY SHUT DOWN AND IS NO LONGER FUNCTIONAL. IT WAS REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293307 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1