BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 2013426 · Received February 3, 2011

    Report

    Report Number
    3003873069-2011-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 15, 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

    DEVICES USED FOR EVALUATION WERE NON-CLINICAL TOMOTHERAPHY-OWNED SYSTEMS BUT WERE CLINICAL PRODUCTION EQUIVALENT.

    Description of Event or Problem · 1

    WITH SOME SPECIFIC PLAN TYPES, THE TREATMENT PLANNING SYSTEM CAN OVER PREDICT DOSE TO TARGETS RESULTING IN POTENTIAL UNDER DOSE. THE PLAN ELEMENTS NECESSARY TO ENCOUNTER THIS ISSUE ARE SHARP DOSE GRADIENTS WITH FEW, SIMPLE AND SMALL AXIAL CROSS SECTION TARGETS LOCATED OFF CENTRAL AXIS.

    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