BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS AUTO, AED, AHA 2010, US ENGLISH

    MDR report key: 11096122 · Received December 30, 2020

    Report

    Report Number
    2112020-2020-01122
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    December 10, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FULL FUNCTIONAL TESTING AND DWM SELF-TESTING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION RESULTED IN NO FINDINGS. THE ERRORS WERE CLEARED PRIOR TO RECEIVING THE DEVICE FOR EVALUATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE ELECTRODE PADS USED WERE NOT RETURNED AS PART OF THIS INVESTIGATION. 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 FAILED FOR HIGH IMPEDANCE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560567 G3 PLUS AUTO, AED, AHA 2010, US ENGLISH AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A-1001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1