BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G3 AED

    MDR report key: 2172457 · Received June 24, 2011

    Report

    Report Number
    3014398-2011-00007
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K031987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER IS UNWILLING TO SEND THE DEVICE IN FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOLLOWING: DURING VITAL SIGN CHECK THE PT WAS DISCOVERED NOT TO BE BREATHING AND DID NOT HAVE A PULSE. THE PT WAS A DNR. STAFF RETRIEVED THE AED TO VERIFY ABSENCE OF A HEART RATE. BOTH PADS WERE APPLIED TO THE PT'S CHEST AND THE MACHINE GAVE THE MESSAGE "APPLY SECOND PAD". BOTH PADS WERE READJUSTED TWICE AND A SET OF NEW PADS WERE APPLIED. THE AED CONTINUED TO GIVE THE SAME MESSAGE AFTER ALL THREE ATTEMPTS TO ADJUST AND REPLACE THE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERHEART G3 AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening