BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART PLUS AUTOMATIC AED

    MDR report key: 2211875 · Received August 8, 2011

    Report

    Report Number
    3014398-2011-00008
    Event Type
    Death
    Date Received
    August 8, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K052161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HASN'T RETURNED DEVICE TO CARDIAC SCIENCE FOR EVAL YET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A RESCUE ATTEMPT THE DEVICE CONTINUED TO PROMPT THE USER TO PLACE ELECTRODES ON THE PT AND NEVER ADVANCED BEYOND THAT PROMPT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death