BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE, AED

    MDR report key: 1253281 · Received December 5, 2008

    Report

    Report Number
    3003521780-2008-00024
    Event Type
    Death
    Date Received
    December 5, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE ACTUAL DEVICE WAS EVALUATED, HOWEVER, THE DEFIBRILLATION PADS USED DURING THE RESCUE ATTEMPT WERE NOT AVAILABLE AND WERE REPORTED TO HAVE BEEN DISPOSED OF AFTER USE. THE DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. RECORDS FOR DEFIBRILLATION PADS BELIEVED TO BE FROM THE SAME LOT AS THE PADS THAT WERE USED ALSO REVIEWED. THE RECORDS INDICATE THAT THE LOT PASSED REQUIRED QUALITY INSPECTION, AND TESTING PARAMETERS. RESULT CODE: THE DEFIBRILLATION PADS WERE NOT RETURNED, NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    IN 2008, THERE WAS A REPORT THAT DURING A RESCUE ATTEMPT, DEFIBRILLATION PADS WERE REPORTED TO HAVE BEEN APPLIED TO THE PATIENT, AND CONNECTED TO THE DEVICE, HOWEVER, THE DEVICE REPORTED A CONNECT PADS PROMPT. IT IS BELIEVED THAT THE PATIENT DID NOT SURVIVE.

    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 80 YR Death