BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 1942057 · Received November 9, 2010

    Report

    Report Number
    3003873069-2010-00004
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 9, 2010
    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 4.0.2 AND 4.0.3. (B)(4).

    Description of Event or Problem · 1

    TOMOTHERAPY HAS DISCOVERED AN ANOMALY DURING INTERNAL TESTING. WHEN A TOMODIRECT PROCEDURE HAS AN UNRECOVERABLE INTERRUPT IN BETWEEN BEAM ANGLES THERE IS A SLIGHT POSSIBILITY THAT THE PROCEDURE WILL INDICATE A "PERFORMED" STATUS RATHER THAN "INTERRUPTED" ON THE OPERATOR STATION.

    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