BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G5 KIT, SEMI, US ENG/ESP LA

    MDR report key: 20710037 · Received November 18, 2024

    Report

    Report Number
    2112020-2024-00912
    Event Type
    Death
    Date Received
    November 18, 2024
    Date of Event
    October 28, 2024
    Report Date
    October 28, 2024
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021284
    PMA / PMN Number
    P160033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION RESULTED IN NO FINDINGS. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE CLINICAL LOGS CONFIRMED THAT A PATIENT IMPEDANCE WAS NEVER RECOGNIZED BY THE DEVICE ON THE EVENT DATE OF 10/28/2024. THE ELECTRODE PADS RECEIVED AS PART OF THE INVESTIGATION ALSO SUGGEST THEY WERE NOT APPLIED TO A PATIENT. THE LAST PATIENT IMPEDANCE MEASUREMENT IN THE LOG WAS ON (B)(6) 2024. THERE IS ACTIVITY ON (B)(6) 2024, WHERE THE LID IS OPENED MANY TIMES AND CLOSED WITHOUT THE ELECTRODES ATTACHED. THIS PROMPTS THE DEVICE TO PROVIDE ERRORS AND LITE THE BANNER INDICATING SERVICE IS REQUIRED. THIS IS REPEATED AS THE LID IS OPENED AND CLOSED MULTIPLE TIMES. THERE APPEARS TO BE NO MALFUNCTION WITH THE DEVICE, AND THE LOG SUPPORTS THE ELECTRODE PADS WERE NOT APPLIED TO THE PATIENT. 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 MONITOR 50-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090125 POWERHEART G5 KIT, SEMI, US ENG/ESP LA AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-80C NA 00812394021284

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Death