BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS AUTO, AED, AHA 2010, BRITISH

    MDR report key: 13178855 · Received January 6, 2022

    Report

    Report Number
    2112020-2021-01348
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Report Date
    December 16, 2021
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    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 DAILY/WEEKLY/MONTHLY SELF TEST USING TEST PADS WITHOUT DUPLICATING THE REPORT. THE REPORT WAS MANUALLY CLEARED PRIOR TO EVALUATION AND DID NOT REOCCUR. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE 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 · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA PADS. 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
    1183063 G3 PLUS AUTO, AED, AHA 2010, BRITISH AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A-1002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown