BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS AUTO, AED, AHA 2010, US ENGLISH

    MDR report key: 9683153 · Received February 7, 2020

    Report

    Report Number
    2112020-2020-00037
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Report Date
    January 17, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. PLEASE REFER TO MEDWATCH 2112020-2020-00085 FOR THE INVESTIGATION RESULTS.

    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 WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146623 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