BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC - NOVALIS TX

    MDR report key: 2550249 · Received April 19, 2012

    Report

    Report Number
    2916710-2012-00016
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K081188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GANTRY CHAIN WAS REPLACED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS POSSIBLE SITUATION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE GANTRY CHAIN BROKE AT THE MIDDLE OF THE TREATMENT. THE LINK BLOCK OF THE CHAIN HAD COME OUT. THE GANTRY CHAIN CLAMPING CLIP HAD BROKEN, AND THE LINK BLOCK HAD BEEN DAMAGED. THIS HAPPENED DURING A TREATMENT CONSISTING OF SEVEN FIELDS. THREE OF THE SEVEN FIELDS HAD BEEN COMPLETED AND THE GANTRY WAS MOVING TO THE PLANNED POSITION FOR THE FOURTH FIELD. THE CHAIN WAS REPLACED. NO MISTREATMENT OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC - NOVALIS TX ACCELARATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC H29

    Patients

    Seq Age Sex Outcome Treatment
    1