BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART AED G3

    MDR report key: 6397093 · Received March 10, 2017

    Report

    Report Number
    2112020-2017-00003
    Event Type
    Death
    Date Received
    March 10, 2017
    Date of Event
    February 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K102496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AED WAS RECEIVED AT CARDIAC SCIENCE (CSC) FOR INVESTIGATION. DATA RECORDED AT THE TIME OF THE RESCUE WAS DOWNLOADED FROM THE AED FOR CLINICAL AND TECHNICAL REVIEW. THE RESCUE DATA DOESN'T SUPPORT THE AED PERFORMANCE DESCRIBED BY THE CUSTOMER. THE CUSTOMER REPORTED THE AED ANALYZED THE PATIENT'S RHYTHM MULTIPLE TIMES AND DETERMINED THE PATIENT DIDN'T HAVE A SHOCKABLE RHYTHM. THE RESCUE DATA SHOWS ONLY ONE ANALYSIS SESSION WAS PERFORMED. THE PATIENT'S ECG DATA DISPLAYED DURING THE ANALYSIS SESSION WAS A NON-SHOCKABLE ASYSTOLE RHYTHM AND NO SHOCK WAS ADVISED. THE RESCUER WAS THEN PROMPTED TO PERFORM CPR. BEFORE THE 2 MINUTE CPR SESSION WAS COMPLETED, THE AED'S LID WAS CLOSED, THE LID WAS REOPENED, AND THE DEVICE RESUMED CPR. THE LID WAS CLOSED AND REOPENED AGAIN AND THE AED RESUMED CPR ONCE MORE. TWO (2) SECONDS AFTER THE CPR SESSION WAS COMPLETED, THE AED DETECTED THAT ELECTRODES WERE OFF AND THE LID OF THE AED WAS CLOSED. INFORMATION PROVIDED BY THE CUSTOMER INDICATES THEY THOUGHT THE AED WAS ANALYZING THE PATIENT'S RHYTHM WHILE THEY WERE PERFORMING CPR. BY DESIGN THE AED PROMPTS THE USER TO STOP CPR AND NOT TOUCH THE PATIENT PRIOR TO RHYTHM ANALYSIS. THE RESULTS OF THE CLINICAL AND TECHNICAL DATA REVIEWS DETERMINED THAT THE AED WORKED AS DESIGNED DURING THE RESCUE. IT CORRECTLY CATEGORIZED THE PATIENT'S ASYSTOLE RHYTHM AS NONSHOCKABLE AND PROMPTED CPR. AN EVALUATION OF THE AED WAS PERFORMED. THERE WERE NO PROBLEMS WITH OFF CURRENT TESTS. IMPEDANCE TESTING FOUND THE AED ACCURATELY DETECTED IMPEDANCE WITHIN THE HUMAN IMPEDANCE RANGE AND THE AED SUCCESSFULLY DELIVERED SHOCKS INTO A DEFIBRILLATION ANALYZER. AED SELF-TESTS WERE RUN EVERY 30 SECONDS FOR 30 MINUTES AND NO ERRORS WERE GENERATED. THE AED WAS OPENED AND MEASUREMENTS OF INTERNAL COMPONENTS FOUND NO PROBLEMS. VISUAL INSPECTION OF THE MAIN PCBA USING A MICROSCOPE FOUND NO DEFECTS. WITH THE USE OF A DEFIBRILLATOR ANALYZER, SIMULATED RESCUES WERE PERFORMED IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. THE AED CORRECTLY IDENTIFIED NON-SHOCKABLE RHYTHM, ADVISED NO SHOCK, AND PROMPTED FOR CPR. WHEN PRESENTED WITH SHOCKABLE RHYTHMS, THE AED CORRECTLY ADVISED FOR SHOCK DELIVERY AND SUCCESSFULLY DELIVERED SHOCKS AFTER THE SHOCK BUTTON WAS PRESSED. NO HARDWARE FAILURES WERE FOUND AND THE AED PERFORMED CORRECTLY DURING TESTING. THE PROBLEM REPORTED BY THE CUSTOMER WASN'T DUPLICATED. THE AED WILL BE SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(6) VOLUNTEER FIRE DEPT. ARRIVED AT THE SCENE OF AN ELDERLY FEMALE PATIENT IN CARDIAC ARREST. THE TIME BETWEEN DISPATCH AND ARRIVAL AT THE SCENE WAS BETWEEN 3 AND 4 MINUTES. CPR WAS INITIATED AND THE AED AND PADS WERE PLACED ON THE PATIENT. THE AED ADVISED IT WAS ANALYZING THE PATIENT A TOTAL OF 3 TIMES AFTER PLACING THE PADS ON THE PATIENT AND DID NOT ADVISE A SHOCK WAS NEEDED AND TO CONTINUE OR BEGIN CPR. THE CUSTOMER INDICATED CPR WAS BEING PERFORMED WHILE THE AED ANALYZED THE PATIENT. THE AMBULANCE ARRIVED ON THE SCENE THE LAST TIME THE AED WAS ANALYZING THE PATIENT. THE MED UNIT ATTACHED THEIR MONITOR AND PADS TO THE PATIENT AND THEIR MONITOR READ V-FIB. THE PARAMEDIC ADVISED A SHOCK WAS NEEDED AND ONE (1) SHOCK WAS DELIVERED. CPR WAS CONTINUED AFTER NO CONVERSION. VARIOUS PROCEDURES AND DRUGS WERE ADMINISTERED BY THE PARAMEDIC AND ANOTHER SHOCK WAS DELIVERED. AFTER SOME TIME THE PATIENT HAD A FAINT PULSE AND WEAK RHYTHM. THE PATIENT WAS LOADED INTO THE AMBULANCE AND DRIVEN TO (B)(6) MEDICAL CENTER ((B)(6)). WHILE WORKING ON THE PATIENT IN THE AMBULANCE THE PATIENT'S RHYTHM WAS LOST AND REGAINED 2 ADDITIONAL TIMES. AT THE TIME OF ARRIVAL AT (B)(6) THE RHYTHM WAS LOST AGAIN AND CPR WAS CONTINUED WHILE TAKING THE PATIENT TO THE ROOM. PATIENT CARE WAS TRANSFERRED TO (B)(6) PERSONNEL AND THEY CONTINUED TO WORK ON THE PATIENT. THE MD AT (B)(6)CALLED THE PATIENT DECEASED AFTER WORKING ON THE PATIENT FOR A SHORT TIME IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177657 POWERHEART AED G3 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death