BEUDAMED
    FDA Adverse Event Summary report: N

    TRUEBEAM STX

    MDR report key: 2507756 · Received March 22, 2012

    Report

    Report Number
    2916710-2012-00015
    Date Received
    March 22, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 23, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K111106
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS REPRODUCED. THE ZONE RULES ARE NOT ENFORCED DURING AUTOMATED FIELD-TO-FIELD TRANSITIONS. MOREOVER, LASERGUARD IS NOT ENABLED. THEREFORE, THERE WAS NO WAY TO PREVENT THE GANTRY FROM ROTATING ONTO THE PT IN THIS SCENARIO. DURING THE TRANSITION BETWEEN FIELDS 3 AND 4, THE RADIATION THERAPIST (RT) OBSERVED THAT THE GANTRY WAS APPROACHING THE PT AND PRESSED THE DEDICATED KEYBOARD (DKB) BEAM OFF BUTTON TO INTERRUPT TREATMENT. THE RT LOWERED THE COUCH, ROTATED THE COUCH TO 0.0, (190.0), ROTATED THE COUCH BACK TO 90 DEG, THEN RESUMED TREATMENT. NO REPORT OF INJURY WAS RECEIVED. AN INTERNAL CORRECTIVE ACTION HAS BEEN ESTABLISHED TO ADDRESS THIS ISSUE ((B)(4)). NO FURTHER F/U TO THIS MDR IS ANTICIPATED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE THERAPIST AUTOMATED TWO FIELDS IN A PLAN, RESULTING IN THE GANTRY COMING INTO CONTACT WITH THE PT'S HAND. THERAPISTS STOPPED GANTRY ROTATION WHEN THE MACHINE TOUCHED THE PT. THERE WAS NO INJURY THAT REQUIRED ANY MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEBEAM STX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC H19

    Patients

    Seq Age Sex Outcome Treatment
    1