BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1964087 · Received December 20, 2010

    Report

    Report Number
    2916710-2010-00149
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS EVENT, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IN THE MIDDLE OF A VMAT TREATMENT (6X), HWFA OF Y2 JAW WAS ACTIVATED. THE USER PRESSED ENTER TO CLEAR IT AND THE JAW STARTED TO MOVE TO ITS PLANNED POSITION. THEN THE PHYSICIST TRIED TO MOVE THE JAWS FROM (Y1-14CM, Y2-10CM, X1-9CM, X2-8CM) TO (Y-1CM, X-1CM) TO VERIFY THE HWFA. BUT THEY NOTICED THAT THE IPSN DOES NOT ACTIVATE. THEY DECIDED TO RELOAD THE PLAN AND RETRIED THE SAME ACTION, BUT THE IPSN ACTIVATES CORRECTLY BY THEN. THUS THE INCIDENT CANNOT BE REPRODUCED. IPSN IL DOES NOT ACTIVATE AS IT SHOULD. PHYSICIST USED THE MANUAL CONTROL OF CLINAC CONSOLE KEYBOARD TO CHANGE BOTH JAWS FIELD SIZE FROM (Y1-14CM, Y2-10CM, X1-9CM, X2-8CM) TO (Y-1CM, X-1CM) TO VERIFY HWFA. BUT THE IPSN FAILED TO ACTIVATE. THERE WAS A PATIENT ON THE TABLE AT THE TIME OF THE EVENT. HOWEVER, NO REPORT OF SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS H29

    Patients

    Seq Age Sex Outcome Treatment
    1