BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1961427 · Received January 6, 2011

    Report

    Report Number
    2916710-2010-00157
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN MISTREATMENT AND CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER WAS CHECKING CHART AND NOTICED THAT THE DOSE TO DATE WAS INCORRECT BY 1.5 CGY. HE SPOKE TO THE THERAPIST AND THEY WERE NOT SURE WHY OR WHAT HAPPENED BUT RECALL SOME NETWORK ISSUES THAT DAY. THE SCREEN SHOTS WERE REVIEWED AND IT WAS FOUND THAT ONE FIELD WAS FIELD RECORDED TWICE AND ONE FIELD APPEARS TO HAVE BEEN SKIPPED IN THE HISTORY TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS 4DITC

    Patients

    Seq Age Sex Outcome Treatment
    1