BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 1495845 · Received August 27, 2009

    Report

    Report Number
    3003873069-2009-00002
    Event Type
    Malfunction
    Date Received
    August 27, 2009
    Date of Event
    August 21, 2009
    Report Date
    August 26, 2009
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN ANOMALY IN SW 2.4 AND 3.XX. URGENT MEDICAL DEVICE NOTIFICATION. EVALUATION TO BE PROVIDED IN FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DURING RADIATION TREATMENT THE THERAPIST NOTICED THAT THE USUAL DATA OF TREATMENT (DOSE RATE, MU'S, AND PROCEDURE TIME) WERE NOT VISIBLE ON THE OS DISPLAY, EVEN THOUGH THE RAD ON INDICATORS WERE ACTIVE. THE TREATMENT WAS THEN STOPPED WHEN THE THERAPIST HIT THE "STOP" BUTTON ON THE STATUS CONSOLE AT THE 180.4 SEC MARK. THE PROCEDURE DURATION WAS SCHEDULED FOR 406.5 SECONDS. THE USER THEN IMMEDIATELY CONTACTED TOMOTHERAPY AS INSTRUCTED IN "URGENT MEDICAL DEVICE NOTICE", DATED AUG 10, 2009. THE CUSTOMER REPORTED THERE WAS NO PT INJURY.

    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