BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4DITC

    MDR report key: 1976616 · Received January 26, 2011

    Report

    Report Number
    2916710-2010-00167
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER DESIGN, USERS SHOULD NOT BE ABLE TO EDIT MU. THE INFORMATION ON MU, MAX DOSE RATE, AND TREATMENT TIME ARE AUTOMATICALLY TRANSFERRED TO THE CLINIC CONTROLLER. USER CAN NOT CHANGE THE MU, THE TREATMENT TIME, OR THE DOSE RATE. SCREEN SHOTS OF THE AVAILABLE EDIT TO MU HAVE BEEN OBTAINED. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING RAPID ARC COMMISSIONING, THE PHYSICIST NOTED THAT THE MONITOR UNIT FIELD IS AVAILABLE FOR EDITS WHEN USING OPTION 'EDIT PLAN' AT 4D. CUSTOMER IS ABLE TO EDIT THE MONITOR UNITS WHEN USING THE AD HOC 4D OPTION 'EDIT PLAN' FOR A RAPID ARC PLAN. THE MONITOR UNIT, COUCH VRT, LAT, LNG AND SSD ARE ALL AVAILABLE FOR EDITS AT THIS SITE. THE SITE HAS TWO MACHINES THAT ARE CAPABLE OF RAPID ARC, ONE ON EACH CAMPUS, BOTH HAVE THE SAME BEHAVIOR OF BEING ABLE TO EDIT MU AT 4D. NO INJURY OR MISADMINISTRATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4DITC DELIVERY SYSTEMS IYE VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1