BEUDAMED
    FDA Adverse Event Death Summary report: N

    G3 PLUS AUTO, AED, AHA 2010, GERMAN

    MDR report key: 19418793 · Received May 29, 2024

    Report

    Report Number
    2112020-2024-00455
    Event Type
    Death
    Date Received
    May 29, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 21, 2024
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED (JUSTIFICATION FOR NO UDI: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION). THE DEVICE AND ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE DEVICE WAS FUNCTIONALLY TESTED WITHOUT DUPLICATING A FAULT TO THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORT. IT IS IMPORTANT TO NOTE THE DEVICE WAS CAPABLE OF DELIVERING THERAPY AND THE GEL PROVIDES ADDITIONAL ASSURANCES FOR PATIENT COUPLING. THE DEVICE WILL BE RECERTIFIED AND RETURNED TO THE CUSTOMER. EVALUATION OF THE ELECTRODES CONFIRMS THE CUSTOMER'S REPORT OF THE GEL PARTIALLY PEELING AWAY FROM THE ELECTRODE. GEL PEELING IS MITIGATED THROUGH LABELING/ ILLUSTRATIONS IN THE IFU AND PHYSICALLY THROUGH A REINFORCED "TAPE LANE" SEEN ON THE LOWER EDGE OF THE BOTTOM PAD. THERE IS DAMAGE PRESENT ON THE CORNER OF THE FOAM WHICH IS EVIDENCE THAT THE USER DID NOT FOLLOW THE ILLUSTRATIONS ON THE ELECTRODE PAD SET FOR OPENING THE PACKAGING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 51-YEAR-OLD FEMALE PATIENT, THE ELECTRODE PADS WERE DAMAGED AFTER REMOVING THEM FROM THE PACKAGING AND WAS NOT POSSIBLE TO ATTACH THE ELECTRODES TO THE PATIENT OR DEFIBRILLATE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593673 G3 PLUS AUTO, AED, AHA 2010, GERMAN AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A-1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Death