BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE AED

    MDR report key: 3916149 · Received June 6, 2014

    Report

    Report Number
    3003521780-2014-00011
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE REPORTED EVENT, THE ACTUAL DEVICE BATTERY PACK AND DEFIBRILLATION PADS USED DURING THE EVENT WERE REQUESTED IN ORDER TO SIDE IN THE INVESTIGATION. ON (B)(4) 2014 THE AED AND BATTERY PACK ASSOCIATED WITH THIS COMPLAINT WERE RECEIVED. THE INVESTIGATION IS CURRENTLY IN PROCESS AND CONCLUSIONS HAVE BEEN MADE AT THIS TIME. BASED ON THE OUTCOME OF THE INVESTIGATION, SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT AN AED WAS CONNECTED TO A PT SIMULATOR AND WAS BEING TESTED. DURING TESTING, THE AED ADVISED AND DELIVERED A DEFIBRILLATION SHOCK. AFTER THE AED ADVISED A SECOND DEFIBRILLATION SHOCK, IT WAS REPORTED THAT THE AED POWERED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331111 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A-EN NA

    Patients

    Seq Age Sex Outcome Treatment
    1