BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC 21EX

    MDR report key: 2436038 · Received January 17, 2012

    Report

    Report Number
    2916710-2011-00153
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 6, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS REPRODUCED. IMMEDIATE CORRECTION: WINDUP CABLES WERE REPLACED. ALL SYSTEMS QA CHECKED OK ACCORDING TO STAFF. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS A APPROPRIATE, AS THIS SITUATION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    STAFF NOTICED THAT CLINAC LOWER X-1 JAW MOVED DURING TREATMENT. THE PORTAL VISION IMAGE DURING TREATMENT SHOWED THAT X-1 JAW MOVED TO -2 CM. NO CLINAC INTERLOCKS APPEARED DURING THIS EVENT. THE STAFF WENT INTO THE TREATMENT ROOM TO CHECK JAW SITUATION, AND ACCORDING TO STAFF THE COLLIMATOR STARTED MOVING SEVERAL DEGREES ON TIS OWN. THEY SHUT THE CLINAC DOWN AND REMOVED THE PT USING EMERGENCY POWER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 21EX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H27

    Patients

    Seq Age Sex Outcome Treatment
    1