BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY WITH MIRS

    MDR report key: 2003794 · Received February 7, 2011

    Report

    Report Number
    2916710-2011-00006
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A KNOWN ISSUE, PREVIOUSLY REPORTED AND INVESTIGATED. VARIAN HAS BEEN ABLE TO CONFIRM THE USER'S ALLEGATION: THE MLC CAN BE WRONGLY MIRRORED FOR COLL RTN BETWEEN 315 TO 359.9. NOT ALL ANGLES IN THIS AREA LEAD TO WRONG MLC WHEN CREATING AN OPPOSING FIELD. THIS BEHAVIOR IS DUE TO A ROUNDING PROBLEM IN THE APPLICATION. RT CHART/ECLIPSE CALCULATES EXACT VALUES WITH ROUNDED VALUES. THE ANOMALY IS REPRODUCIBLE WITH ARIA 8.9.09 VERSIONS. WITH ALL COLL RTN ANGLES OUT OF THE AFFECTED RANGE (315 - 359.9), THE MLC IS CORRECTLY MIRRORED WHEN CREATING AN OPPOSING FIELD. IN ORDER TO MITIGATE RECURRENCE OF THIS ISSUE FOR CURRENT USERS, A CUSTOMER TECHNICAL BULLETIN (CTB) WILL BE PROVIDED TO FURTHER DESCRIBE THE BEHAVIOR AND INSTRUCT ON THE AVAILABLE WORKAROUND. THERE WAS NO INJURY OR MISTREATMENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    FIELD CREATED IN RT CHART AND XIMAVISION STAND-ALONE WITH VARIOUS COLLIMATOR ANGLES WITH MLC DO NOT OPPOSE CORRECTLY. IN THE WORKSPACE "PARAMETERS" OF RT CHART, THE OPTION "CREATE OPPOSING FIELD" ON AN ANTERIOR FIELD (GANTRY 0 DEGREE) TO CREATE A POSTERIOR FIELD (GANTRY 180 DEGREES) DID NOT WORK CORRECTLY FOR A PATIENT. THE FIELD APERTURE SHOWN IS CORRECT BUT MLC POSITIONS ARE WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY WITH MIRS TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS HIT

    Patients

    Seq Age Sex Outcome Treatment
    1