BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 2185450 · Received July 12, 2011

    Report

    Report Number
    3003873069-2011-00004
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 11, 2011
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K082005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN ANOMALY IN TOMOTHERAPY HI-ART SW 4.0. X AND HD 1.0.X.

    Description of Event or Problem · 1

    TOMOTHERAPY WAS INTERNALLY IDENTIFIED AN ISSUE THAT MAY OCCUR DURING DICOM EXPORT OF PLAN LEVEL IMAGES WITH A NON SQUARE EXPORTED FIELD OF VIEW (FOV). THE PROCESS OF SQUARING THE PLAN LEVEL IMAGE, MAY CAUSE THE IMAGE TO SHIFT WITH RESPECT TO REGIONS OF INTEREST (ROIS) AND DOSE. WHEN THE ANOMALY OCCURS, THE MAGNITUDE OF THE IMAGE SHIFT WILL BE EITHER A FULL LATERAL, A FULL VERTICAL VOXEL OR BOTH. THE ANOMALY DOES NOT OCCUR WITH EVERY DICOM EXPORT AND IS DEPENDENT ON SPECIFIC IMAGE DIMENSIONS AND VOXEL SIZES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-ART SYSTEM IYE AND MUJ IYE TOMOTHERAPY INCORPORATED H-0000-0003

    Patients

    Seq Age Sex Outcome Treatment
    1