BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIART SYSTEM

    MDR report key: 1632009 · Received March 4, 2010

    Report

    Report Number
    3003873069-2010-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    October 20, 2009
    Report Date
    March 4, 2010
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K082005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL SOFTWARE CODE USED IN DEVICE EVALUATED. ACTUAL PATIENT TREATMENT DATA EVALUATED.

    Description of Event or Problem · 1

    DURING RADIOTHERAPY PLANNING, THE HI-ART (VER 4.0 AND 4.0.1 SOFTWARE) SYSTEM UPDATES THE IMPORTED DIAGNOSTIC CT COUCH IMAGE PORTION OF THE PATIENT'S IMAGE TO THE HI-ART RADIOTHERAPY COUCH. IN SOME CASES, THE PATIENT'S DIAGNOSTIC CT IMAGE IS NARROWER THAN THE HI-ART RADIOTHERAPY COUCH IMAGE. IN THESE CASES THE PATIENT'S DIAGNOSTIC CT MUST BE INCREASED IN WIDTH TO ACCOMMODATE THE HI-ART RADIOTHERAPY COUCH WIDTH. THIS MAY RESULT IN THE PATIENT'S REGIONS OF INTEREST CONTOURS BEING SHIFTED LATERALLY FROM THE INTENDED POSITION BY UP TO 5MM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1