BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 964492 · Received December 14, 2007

    Report

    Report Number
    3003873069-2007-00001
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 15, 2007
    Report Date
    December 14, 2007
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE PILOT COUCH LOST COMMUNICATION WITH THE SYS COMPUTER, RESULTING IN THE INABILITY TO PROCESS THE MANUAL STOP COMMAND. IT WAS DETERMINED THAT THIS ISSUE CAN ONLY OCCUR DURING THE PT SETUP PROCESS WHEN THE USER IS UTILIZING THE MANUAL MOVE BUTTONS. PRESSING THE E-STOP BUTTON WILL STOP COUCH MOVEMENT. IT WAS ALSO DETERMINED THAT THIS ISSUE CANNOT OCCUR DURING THE ADMINISTRATION OF RADIATION. USERS OF THE THREE AFFECTED PILOT COUCHES HAVE BEEN NOTIFIED (NOTICE ATTACHED) AND REMINDED OF THE USE OF THE E-STOP BUTTON. A HARDWARE MODIFICATION WILL BE UNDERTAKEN TO ALLOW FOR APPROPRIATED HANDLING OF SUCH A COMMUNICATION LOSS.

    Description of Event or Problem · 1

    DURING A MANUAL HORIZONTAL DIRECTIONAL SETUP MOVE OF THE PT POSITIONING TABLE INTO THE BORE OF THE GANTRY, THE USER RELEASED THE DIRECTIONAL AND ENABLE BUTTONS TO STOP THE COUCH, BUT THE COUCH CONTINUED TO MOVE INTO THE GANTRY. THE COUCH STOPPED ONCE THE MAXIMUM HORIZONTAL LIMIT WAS REACHED. THE PT WAS REPOSITIONED AND TREATED NORMALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR