BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC, CL-600C/D

    MDR report key: 1991515 · Received January 28, 2011

    Report

    Report Number
    2916710-2010-00170
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K862645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THIS ALLEGATION BE CONFIRMED, THERE IS A POTENTIAL FOR THE GANTRY TO COLLIDE WITH A PATIENT OR USER, WHICH WOULD BE LIKELY TO CAUSE AN ADVERSE EVENT. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION SHOULD IT RECUR, COULD POTENTIALLY RESULT IN MISADMINISTRATION AND SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UNEXPECTED GANTRY ROTATION. DURING A FIXED 6MV MORNING CHECKOUT MEASUREMENT, THE TECHNICIAN NOTICED THAT THE GANTRY HAD BEEN ROTATING AND THEY STOPPED THE BEAM. THE GANTRY ANGLE ON THE CONSOLE SCREEN READ 22 DEGREES, THE MEASUREMENTS MADE DURING THIS PERIOD DID NOT READ CORRECTLY AND WERE BEING REPEATED. THERE WAS NO REPORT OF INJURY OR MISADMINISTRATION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC, CL-600C/D SYSTEM, LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS H18

    Patients

    Seq Age Sex Outcome Treatment
    1