BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G5 KIT,SEMI,US EN/FRN CA, CPR

    MDR report key: 20878434 · Received December 9, 2024

    Report

    Report Number
    2112020-2024-01002
    Event Type
    Death
    Date Received
    December 9, 2024
    Report Date
    November 18, 2024
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTION B1, B2, B5, H1, AND H6 (HEALTH EFFECT IMPACT CODE). THE CUSTOMER RESPONDED TO ZOLL MEDICAL CORPORATION'S REQUESTS REGARDING INFORMATION RELATED TO PATIENT PREPARATION, IF THE DEFIB PADS WERE PLACED PROPERLY, OR IF THE PADS WERE DAMAGED DURING REMOVAL. THE CUSTOMER STATED NO SKIN PREPARATION WAS BELIEVED TO BE DONE AND THE PLACEMENT OF THE PADS "APPEARED" CORRECT. THE PADS WERE DISPOSED OF WHEN THEY WERE REMOVED FROM THE PATIENT SO THEY ARE NOT AVAILABLE FOR EVALUATION.

    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. THE DEVICE FUNCTIONED AS INTENDED. THE ELECTRODE PADS USED WERE NOT RETURNED AS PART OF THIS INVESTIGATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS SHOWED "22C" ERROR WHICH WAS CAUSED BY THE PADS NOT BEING CONNECTED PROPERLY. POTENTIAL CAUSES CAN BE DAMAGED, POOR ADHESIVE, OR IMPROPER PLACEMENT OF THE PADS. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

    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. 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 PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY PROMPTED AN "ATTACH PADS" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORT 2112020-2024-00995 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY PROMPTED AN "ATTACH PADS" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 2112020-2024-00995 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97547 POWERHEART G5 KIT,SEMI,US EN/FRN CA, CPR AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-90C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death