BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 1265592 · Received December 16, 2008

    Report

    Report Number
    3003521780-2008-00027
    Event Type
    Death
    Date Received
    December 16, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 17, 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

    CONCLUSION CODE: OTHER - A NUMBER OF ATTEMPTS WERE MADE TO CONTACT THE END CUSTOMER, HOWEVER, THE ACTUAL DEVICE INVOLVED HAS NOT BEEN MADE AVAILABLE FOR EVALUATION. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESCUE ATTEMPT THE DEVICE INDICATED THAT A SHOCK WAS ADVISED AND THAT WHEN THE SHOCK BUTTON WAS PRESSED THE DEVICE POWERED OFF. IT IS REPORTED 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 52 YR Death