BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART AED G3

    MDR report key: 1853756 · Received September 3, 2010

    Report

    Report Number
    3014398-2010-00028
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 25, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AED WAS SENT TO CARDIAC SCIENCE CORPORATION FOR INVESTIGATION AND EVALUATION. THE REPORTED PROBLEM WAS NOT DUPLICATED AND THE DEVICE PASSED ALL INCOMING TESTS. THE AED WAS FURTHER EVALUATED; NO FAILURES FOUND AND DEVICE IN GOOD WORKING ORDER. IN ADDITION, THE EVALUATION COULD NOT DUPLICATE THE ERROR CODE LOGGED IN THE RESCUE FILE, OR IDENTIFY A DEFINITIVE ROOT CAUSE OF THE DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    AED WAS USED IN A RESCUE. PADS WERE PLACED ON PATIENT. DEVICE PROMPTED "PREPARING SHOCK, MOVE AWAY FROM PATIENT". WHEN THE SHOCK BUTTON WAS PRESSED, THE AED VOICE PROMPT SAID "SERVICE REQUIRED". AN ERROR CODE WAS ALSO LOGGED IN THE RESULTANT RESCUE FILE. THE RESCUER THEN CHECKED PADS CONNECTION AND ADHESION TO PATIENT SKIN. THE LID OF THE AED WAS THEN CLOSED AND REOPENED AND RESPONDERS WERE ABLE TO CONTINUE WITH THE RESCUE AND SUCCESSFULLY DELIVER A SHOCK. THE PATIENT RECEIVED CPR CONTINUOUSLY UNTIL PARAMEDICS ARRIVED AT THE SCENE AND WAS TRANSFERRED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERHEART AED G3 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9231-509 NA

    Patients

    Seq Age Sex Outcome Treatment
    1