BEUDAMED
    FDA Adverse Event Death Summary report: N

    G3 PLUS AUTO, AED, ENGLISH, PKG

    MDR report key: 10343770 · Received July 30, 2020

    Report

    Report Number
    2112020-2020-00567
    Event Type
    Death
    Date Received
    July 30, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 9, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DATA FILE OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE DATA FILE DID SHOW THAT THE FIRST FOUR ANALYSES THE DEVICE CATEGORIZED THE PATIENT'S RHYTHM AS VENTRICULAR FIBRILLATION AND ADVISED SHOCKS. FOR THE OTHER ANALYSES, THE PATIENT'S RHYTHM WAS BELOW 200 MICROVOLTS AND WERE BELOW THE THRESHOLD AMPLITUDE REQUIRED FOR SHOCKABLE DETERMINATIONS. BASED ON OUR REVIEW OF THE DATA, WE HAVE CONCLUDED THAT THE ANALYSIS RESULTS WERE CORRECT FOR THE SPECIFIC ANALYSES IN QUESTION AND THE DEVICE WORKED WITHIN THE LIMITATIONS OF TEH AVAILABLE TECHNOLOGY. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR OLD MALE PATIENT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810355 G3 PLUS AUTO, AED, ENGLISH, PKG AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death