BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT, AUTO, FRN/INTL ENG

    MDR report key: 10635654 · Received October 6, 2020

    Report

    Report Number
    2112020-2020-00778
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 15, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FULL FUNCTIONAL TESTING AND DWM SELF-TEST WITHOUT DUPLICATING THE REPORT. THE REPORT WAS CLEARED PRIOR TO RECEIVING THE DEVICE FOR EVALUATION. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE PADS USED AT THE TIME OF THE REPORT WERE NOT RETURNED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DETECTED HIGH IMPEDANCE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103413 POWERHEART G5 KIT, AUTO, FRN/INTL ENG AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5A-11A NA

    Patients

    Seq Age Sex Outcome Treatment
    1