BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G3 PLUS AED

    MDR report key: 1970058 · Received January 13, 2011

    Report

    Report Number
    3014398-2011-00001
    Event Type
    Death
    Date Received
    January 13, 2011
    Date of Event
    September 30, 2010
    Report Date
    January 12, 2011
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K052161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HASN'T BEEN EVALUATED YET. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THIS UNIT WAS USED IN A RESCUE AND THE VOICE PROMPTS WOULD NOT ADVANCE PAST THE 'PLACE PADS' PROMPTS. TWO SETS OF PADS WERE USED; HOWEVER, NEITHER SET WOULD ALLOW THE AED TO ADVANCE BEYOND THE 'PLACE PADS' PROMPT. USER PRESSED THE SHOCK BUTTON IN ORDER FOR THE AED TO CLEAR THE PAD PLACEMENT PROMPT AND MOVE TO THE NEXT PROMPT. EMS ARRIVED ON THE SCENE, PLACED THEIR HEART MONITOR ON THE PT, AND SAID THE INDIVIDUAL HADN'T SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERHEART G3 PLUS AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390E-501-NBS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death