BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 2621311 · Received June 13, 2012

    Report

    Report Number
    3003521780-2012-00004
    Event Type
    Death
    Date Received
    June 13, 2012
    Date of Event
    December 11, 2011
    Report Date
    May 22, 2012
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT HAS BEEN REQUESTED TO BE RETURNED TO ASSIST WITH THE INVESTIGATION, HOWEVER, TO-DATE, IT HAS NOT BEEN RECEIVED. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    ON 05/22/2012, IT WAS REPORTED THAT AN AED WAS USED DURING A RESCUE ATTEMPT ON (B)(6) 2011 AND THAT THE AED DID NOT POWER ON WHEN THE POWER-ON BUTTON WAS PRESSED. A SECOND DEFIBRILLATOR WAS ON THE SCENE BUT NEVER DEPLOYED. THE PATIENT WAS NOT RESUSCITATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death