BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 ELITE AUTO, 9790E AED, ENGLISH 9AUSSIE)

    MDR report key: 10339288 · Received July 29, 2020

    Report

    Report Number
    2112020-2020-00582
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Report Date
    July 9, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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-TESTING WITHOUT DUPLICATING THE REPORT. THE REPORT WAS CLEARED FROM THE LOGS. AN INTERNAL INSPECTION FOUND NO DISCREPANCIES. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE OBTAINED AN INCORRECT ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804230 G3 ELITE AUTO, 9790E AED, ENGLISH 9AUSSIE) AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9790A-1031 NA

    Patients

    Seq Age Sex Outcome Treatment
    1