BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART AED G3 AUTOMATIC

    MDR report key: 4495366 · Received February 5, 2015

    Report

    Report Number
    3009249335-2015-00002
    Event Type
    Death
    Date Received
    February 5, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 8, 2015
    Manufacturer
    CARDIAC SCIENCE CORP
    Product Code
    MKJ
    PMA / PMN Number
    K040438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO CARDIAC SCIENCE FOR EVALUATION. INSPECTIONS OF THE MAIN BOARD AND ASSOCIATED HARDWARE AND MEASUREMENTS OF COMPONENTS FOUND NO PROBLEMS. TWO HOURS OF 30 SECOND SELF TESTS WERE PERFORMED WITHOUT ANY ERRORS. THE AED WAS RUN IN STANDBY MODE FOR THREE DAYS, WHICH INCLUDED A MONTHLY SELF TEST, WITHOUT ANY ISSUES. NO PROBLEMS OCCURRED WHEN MULTIPLE SHOCKS WERE DELIVERED WITH THE DEVICE. WHEN OPERATED UNDER NORMAL CONDITIONS THE INVESTIGATION FOUND NO PROBLEMS WITH THE DEVICE. DATA DOWNLOADED FROM THE AED WAS EXAMINED. THE LID OF THE AED WAS OPENED, PADS ATTACHED TO THE PT, AND A RHYTHM ANALYSIS SESSION WAS PERFORMED. THE AED DETERMINED THE PT DIDN'T HAVE A SHOCKABLE RHYTHM AND PROMPTED THE USER TO START CPR. THE USER THEN CLOSED THE LID OF THE AED. THE AED PROMPTED THE USER TO OPEN THE LID AND CONTINUE THE RESCUE. THE USER OPENED THE LID AND THE AED PROMPTED "SERVICE REQUIRED" AND A 0X71 ERROR WAS GENERATED. THE 0X71 ERROR IS A USER RECOVERABLE ERROR THAT IS CLEARED DURING AED SELF TESTS. DURING THE RESCUE THE ERROR WAS CLEARED WHEN THE LID WAS CLOSED IMMEDIATELY AFTER IT WAS GENERATED. AFTER CLEARING THE ERROR THE AED WAS RESCUE READY. THERE WERE NO SELF TEST ERROR CODES PRIOR TO THE RESCUE. DURING THE RESCUE IT APPEARS THE USER DID NOT USE THE AED AS INTENDED AND MAY HAVE BEEN ATTEMPTING TO RESTART OR ADJUST THE DEVICE IN SOME WAY AFTER IT DETERMINED A SHOCK WASN'T ADVISED. THE CUSTOMER HAD BEEN ASKED TO PROVIDE ADDITIONAL DETAILS ABOUT THE RESCUE, BUT HAS NOT DONE SO. THE CUSTOMER'S DEVICE WILL BE SERVICED AND RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AED ONLY WENT THROUGH ONE CYCLE OF VOICE PROMPTS AND THEN GAVE A SYSTEM ERROR. THE PT DIDN'T SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85137 POWERHEART AED G3 AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORP 9300A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death