BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G5 KIT, SEMI, UK

    MDR report key: 15519287 · Received September 30, 2022

    Report

    Report Number
    2112020-2022-01066
    Event Type
    Death
    Date Received
    September 30, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 20, 2022
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE PASSED FULL FUNCTIONAL TESTING AND AN INTERNAL INSPECTION WITHOUT DUPLICATING THE REPORT. THE DEVICE DATA LOG WAS REVIEWED AND FOUND THAT PRIOR TO THE END OF THE CPR CYCLE THE USER CLOSED THE DEVICE LID. THE DEVICE POWERDOWN TESTS DETECTED THE ELECTRODE PADS WERE USED PREVIOUSLY AND WERE NO LONGER FACE TO FACE. THESE ERRORS ARE EXPECTED IF THE PADS USED AT THE BEGINNING OF THE RESCUE WERE ATTACHED WHEN THE LID WAS CLOSED. THE DEVICE THEN PROMPTED "OPEN LID TO CONTINUE RESCUE" AND THE USER OPENED THE LID. THE DEVICE THEN PROMPTS "MAINTENANCE REQUIRED, CONTINUE RESCUE". THE DEVICE PROCEEDS TO RECORD THREE ADDITIONAL RHYTHM ANALYSES AND DETERMINES ALL OF THEM ARE NOT SHOCKABLE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "MAINTENANCE DO NOT SHOCK" MESSAGE. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. COMPLAINANT INDICATED THE CLINICIAN PERFORMED CPR TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170402 POWERHEART G5 KIT, SEMI, UK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-02A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death