BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS, AED, AHA 2010, ENGLISH

    MDR report key: 11204973 · Received January 20, 2021

    Report

    Report Number
    2112020-2021-00072
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Report Date
    January 18, 2021
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394020348
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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-TESTS WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION RESULTED IN NO FINDINGS. THE ERROR WAS 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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED FOR 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
    102258 G3 PLUS, AED, AHA 2010, ENGLISH AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390E-1001 NA 00812394020348

    Patients

    Seq Age Sex Outcome Treatment
    1