BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIMATRON C RADIOTHERAPY TREATMENT SIMULATOR

    MDR report key: 1961444 · Received January 6, 2011

    Report

    Report Number
    8020711-2010-00010
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS UK LTD
    Product Code
    KPQ
    PMA / PMN Number
    K853349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION. IT IS BELIEVED UNLIKELY, HOWEVER, IF THE FIELD WERE DELETED AND THE OPERATOR DID NOT NOTICE, AND NO SUBSEQUENT PRACTICES CAUGHT THE ERROR, TREATMENT COULD RESULT IN AN UNDERDOSE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TREATMENT FIELDS WERE DELETED BY THE SYSTEM DURING SIMULATION. UPON SAVING THE IMAGES, A SYSTEM WARNING MESSAGE APPEARED, STATING THAT ONE ACCORDING FIELD WOULD NOT EXIST FOR ONE OF THE IMAGE GEOMETRY AND WAS DELETED. NO OTHER ERRORS OR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIMATRON C RADIOTHERAPY TREATMENT SIMULATOR SYSTEM, SIMULATION, RADIATION THERAPY KPQ VARIAN MEDICAL SYSTEMS UK LTD XIM-CX

    Patients

    Seq Age Sex Outcome Treatment
    1