BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS, AED, ENGLISH, NB2S

    MDR report key: 15226653 · Received August 15, 2022

    Report

    Report Number
    2112020-2022-00830
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Report Date
    July 25, 2022
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL MEDICAL CORPORATION FO EVALUATION.

    Description of Event or Problem · 0

    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
    287220 G3 PLUS, AED, ENGLISH, NB2S AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390E-501-NB2S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown