BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART AED G3 PLUS AUTOMATIC

    MDR report key: 4745487 · Received May 4, 2015

    Report

    Report Number
    3009249335-2015-00006
    Event Type
    Death
    Date Received
    May 4, 2015
    Date of Event
    April 7, 2015
    Report Date
    June 1, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAULATION YET.

    Additional Manufacturer Narrative · 1

    THE AED, BATTERY, AND PADS USED DURING THE RESCUE WERE RECEIVED FOR EVALUATION. BOTH THE AED AND BATTERY PASSED ALL INCOMING TESTS. REVIEW OF THE AED'S SELF-TEST HISTORY SHOWED SEVERAL PADS RELATED ERRORS AT THE TIME OF THE RESCUE, BUT THERE WERE NO SELF TEST ERRORS PRIOR TO THE RESCUE. THIRTY (30) SECOND SELF TESTS WERE RUN FOR 20 MINUTES WITH ANY ERRORS. TESTING TO VERIFY THE AED COULD DETECT IMPEDANCE ACCURATELY WAS PERFORMED AND NO PROBLEMS WERE FOUND. COMPONENTS THAT COULD IMPACT THE PATIENT IMPEDANCE CIRCUIT WERE MEASURED AND THERE WERE NO FAILURES. VISUAL INSPECTION OF THE MAIN PCBA FOUND NO DEFECTS. A RESCUE SIMULATION WITH A DEFIBRILLATION ANALYZER WAS PERFORMED. AFTER PLACING THE PADS PER THE VOICE PROMPTS, THE AED ADVANCED TO THE ANALYZING RHYTHM VOICE PROMPT WITHOUT ANY PROBLEMS. THE AED SUCCESSFULLY DELIVERED 3 SHOCKS AND CORRECTLY PROMPTED FOR CPR FOLLOWING EACH SHOCK. THE AED FUNCTIONED CORRECTLY DURING THE SIMULATION. EXAMINATION OF THE PADS USED DURING THE RESCUE FOUND THE CONDUCTIVE GEL WAS COMPLETELY MISSING FROM ONE OF THE PADS. THE FOAM BACKING MATERIAL WAS TORN AND THE MATERIAL COVERING THE TERMINAL WAS MISSING. BASED UPON THE CONDITION OF THE PAD, IT IS LIKELY THE GEL CAME OFF PRIOR TO USE. IF THE PADS ARE NOT PEELED FROM THE RELEASE LINER AS DIRECTED BY THE LABELING THEY CAN BE DAMAGED AND THE GEL MAY COME OFF. IF THE GEL IS MISSING WHEN AN ELECTRODE IS PLACED ON A PATIENT THERE MAY BE INSUFFICIENT ELECTRICAL CONTACT WITH THE PATIENT'S SKIN WHICH WOULD CAUSE THE AED TO PROMPT THE USER TO "CHECK PADS".

    Description of Event or Problem · 1

    AFTER THE AED WAS ATTACHED TO A PATIENT DURING A RESCUE ATTEMPT, THE DEVICE KEPT PROMPTING THE USER TO "APPLY PADS" AFTER THE PADS HAD ALREADY BEEN PLACED ON THE PATIENT. THE RESCUER TRIED REPOSITIONING THE PADS, BUT THAT DIDN'T HELP. THE RESCUER THEN PERFORMED CPR. APPROXIMATELY 1 MINUTE AFTER THE EMS ARRIVED, THE PATIENT WAS DECLARED DECEASED. THE CARDIAC ARREST WAS NOT WITNESSED AND IT IS NOT KNOWN HOW LONG THE PATIENT WAS DOWN BEFORE THE AED WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290483 POWERHEART AED G3 PLUS AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death