BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G3 AED

    MDR report key: 5447925 · Received February 19, 2016

    Report

    Report Number
    3009249335-2016-00003
    Event Type
    Death
    Date Received
    February 19, 2016
    Date of Event
    January 21, 2016
    Report Date
    July 11, 2016
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K102496
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL ANALYSIS OF THE RESCUE DATA DOWNLOADED FROM THE AED WAS PERFORMED. DURING THE RESCUE THE AED ANALYZED THE PATIENT'S RHYTHM, DETERMINED THE VF RHYTHM WAS SHOCKABLE, AND STARTED TO CHARGE. AFTER THE DEVICE COMPLETED THE CHARGE AND PROMPTED THE RESCUER TO PRESS THE SHOCK BUTTON, IT DETECTED ELECTRODES COMING OFF, ENDED THE ANALYSIS SESSION, AND PROMPTED THE USER TO CHECK ELECTRODES. SUBSEQUENTLY, THE DEVICE RESTARTED RHYTHM ANALYSIS, DETECTED THE PATIENT'S VF RHYTHM AS SHOCKABLE AND STARTED TO CHARGE. THE DEVICE COMPLETED THE CHARGE AND PROMPTED THE RESCUER TO PRESS THE SHOCK BUTTON TO DELIVER A SHOCK. THE LID OF THE AED WAS CLOSED BEFORE THE SHOCK BUTTON WAS PRESSED AND THERAPY WAS DELIVERED. A 0X71 ERROR WAS RECORDED IN THE AED SELF-TEST HISTORY AND WAS CAUSED BY THE SHOCK BUTTON BEING PRESSED WHEN THE AED WAS PERFORMING A LID-OPEN SELF-TEST. THE 0X71 ERROR IS A USER CORRECTIBLE ERROR AND IT WAS CLEARED IN THE SUBSEQUENT LID-OPEN SELF-TEST. THE RESULTS OF THE DATA ANALYSIS DETERMINED THE AED WORKED AS DESIGNED IN THE RESCUE. IT CORRECTLY CATEGORIZED THE PATIENT'S VF RHYTHM AS SHOCKABLE AND ADVISED SHOCKS. IT CORRECTLY DETECTED ELECTRODE OFF CONDITION AND RESTARTED RHYTHM ANALYSIS. THE CUSTOMER REPORTED PROBLEMS WITH ELECTRODES ADHERING TO THE PATIENT AND THIS WOULD EXPLAIN WHY THERE WAS A CHECK ELECTRODES PROMPT AFTER THE AED FIRST CHARGED AND PROMPTED FOR SHOCK DELIVERY. THE AED WAS EVALUATED. A MULTIMETER WAS USED TO MONITOR THE BEHAVIOR TO THE SHOCK BUTTON AND THE SHOCK BUTTON WASN'T FOUND TO BE STUCK. INSPECTION OF THE RIBBON CABLE BETWEEN THE UI AND MAIN PCBA FOUND NO PROBLEMS. TESTING PERFORMED AFTER RESEATING THE RIBBON CABLE AND AFTER USING A TEST UI PCBA DIDN'T FIND ANY PROBLEMS. INSPECTIONS AND IMPEDANCE MEASUREMENTS OF COMPONENTS FOUND NO PROBLEMS. AED SELF TESTS WERE RUN EVERY 30 SECONDS FOR 90 MINUTES WITHOUT GENERATING ANY ERRORS. SIMULATED RESCUES WERE PERFORMED WITH THE USE OF A DEFIBRILLATION ANALYZER. THE AED FUNCTIONED CORRECTLY AND DELIVERED SHOCKS WHEN THE SHOCK BUTTON WAS PRESSED. NO SERVICE REQUIRED PROMPTS WERE GENERATED. THE AED FUNCTIONED CORRECTLY THROUGHOUT THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AED HAS BEEN RECEIVED AND THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AED WAS DEPLOYED DURING A RESCUE AND PADS WERE PLACED ON THE PATIENT. A SHOCK WAS ADVISED, BUT WHEN THE SHOCK BUTTON WAS PRESSED THE AED SHOWED "SERVICE REQUIRED". A SECOND AED WAS DEPLOYED TO CONTINUE THE RESCUE. THE PATIENT WAS PRONOUNCED AT THE ER. AFTER THE RESCUE THE SELF-TEST HISTORY SHOWED A 0X71 ERROR CODE. THE CARDIAC ARREST WASN'T WITNESSED AND ITS UNKNOWN HOW LONG THE PATIENT WAS DOWN BEFORE THE AED WAS ATTACHED. WHEN ASKED IF THE PADS WERE REMOVED AND REAPPLIED DURING THE RESCUE, THE CUSTOMER RESPONDED YES. THEY HAD TROUBLE PULLING THE PADS APART AND THE BLUE PLASTIC LINER THAT SEPARATES THE PADS WAS STUCK TO THE PADS. WHEN THE PADS WERE PULLED APART THEY DIDN'T ADHERE PROPERLY TO THE PATIENT SO THE PADS WERE REMOVED AND REAPPLIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AED WAS DEPLOYED DURING A RESCUE AND PADS WERE PLACED ON THE PATIENT. A SHOCK WAS ADVISED, BUT WHEN THE SHOCK BUTTON WAS PRESSED THE AED SHOWED "SERVICE REQUIRED". A SECOND AED WAS DEPLOYED TO CONTINUE THE RESCUE. THE PATIENT WAS PRONOUNCED AT THE ER. AFTER THE RESCUE THE SELF-TEST HISTORY SHOWED A 0X71 ERROR CODE. THE CARDIAC ARREST WASN'T WITNESSED AND ITS UNKNOWN HOW LONG THE PATIENT WAS DOWN BEFORE THE AED WAS ATTACHED. WHEN ASKED IF THE PADS WERE REMOVED AND REAPPLIED DURING THE RESCUE, THE CUSTOMER RESPONDED YES. THEY HAD TROUBLE PULLING THE PADS APART AND THE BLUE PLASTIC LINER THAT SEPARATES THE PADS WAS STUCK TO THE PADS. WHEN THE PADS WERE PULLED APART THEY DIDN'T ADHERE PROPERLY TO THE PATIENT SO THE PADS WERE REMOVED AND REAPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103668 POWERHEART G3 AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E

    Patients

    Seq Age Sex Outcome Treatment
    1 Death