BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 1203575 · Received October 16, 2008

    Report

    Report Number
    3003873069-2008-00005
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 16, 2008
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY NOTICE WILL BE SENT TO ALL AFFECTED CUSTOMERS AND A SOFTWARE PATCH WILL BE INSTALLED ON ALL AFFECTED SYSTEMS THAT WILL NOT ALLOW THE SYSTEM TO OPERATE CLINICALLY, IF THIS INTERLOCK IS DISABLED.

    Description of Event or Problem · 1

    THE OPERATOR STATION CALIBRATION PANEL PROVIDES ACCESS TO VIEW AND MODIFY MACHINE SPECIFIC CONFIGURATION SETTINGS. ACCESS TO THESE SETTINGS HAS ALWAYS BEEN RESTRICTED TO INDIVIDUALS WITH APPROPRIATE SECURITY RIGHTS, BEING LIMITED TO ONLY "SUPERUSER" AND "FIELD SERVICE ENGINEER" CATEGORIES. OTHER SECURITY LEVEL USERS, INCLUDING THE "THERAPIST", CANNOT MODIFY THESE SETTINGS. IN THIS CALIBRATION PANEL, IT IS POSSIBLE FOR SUPERUSER AND FIELD SERVICE ENGINEER USER TYPES TO MANUALLY DISABLE THE FRONT AND BACK JAW POTENTIOMETER INTERLOCK. THIS INTERLOCK IS ALWAYS CORRECTLY ENABLED PRIOR TO FACTORY SHIPMENT OF SYSTEMS FROM TOMOTHERAPY, AND THERE ARE NO SERVICE PROCEDURES THAT REQUIRE THE INTERLOCK TO BE DISABLED. IF THIS SETTING WERE TO BE MANUALLY DISABLED, THE JAW WOULD NOT PERFORM A VERIFICATION OF THE PRE-PROCEDURE HOMING ROUTINE. IN THE UNLIKELY EVENT THAT THIS VERIFICATION ROUTINE FAILED IN A RARE AND VERY SPECIFIC MANNER, THE JAWS COULD POSITION INCORRECTLY FOR THAT PROCEDURE WITHOUT A SYSTEM INTERLOCK OCCURRING. THIS POSITIONING ERROR COULD ONLY RESULT IN A FIELD WIDTH THAT IS SMALLER THAN PLANNED. FRACTIONS THAT WOULD BE AFFECTED WOULD ONLY BE THOSE INCURRING THE UNUSUAL CHAIN OF EVENTS OUTLINED ABOVE. REGARDLESS, OVERDOSE IS NOT A POSSIBLE OUTCOME.

    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