BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1961443 · Received January 6, 2011

    Report

    Report Number
    2916710-2010-00154
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT. WARRANTY FOR THIS DEVICE EXPIRED IN SEPTEMBER 2002. THE DEVICE IS NOT COVERED BY CONTRACT AND HAS BEEN MAINTAINED BY CUSTOMER SINCE WARRANTY EXPIRATION. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    MASTER LINK OF THE GANTRY CHAIN BROKE WHILE SWITCHING BETWEEN TREATMENT FIELD WITH A PATIENT ON THE TABLE. THE GANTRY ROTATED CCW FROM PLANNED INITIAL POSITION AND PASSED THRU PLANNED TARGET POSITION, AS CHAIN WAS BROKEN IN THE MIDDLE, GANTRY ROTATED FREELY UNTIL HITTING MECHANICAL STOP. THE MACHINE WAS INSTALLED IN 2001, AND WARRANTY EXPIRED IN SEPTEMBER 2002. MACHINE IS NOT COVERED BY CONTRACT AND HAS BEEN MAINTAINED BY CUSTOMER SINCE WARRANTY EXPIRATION. OBSERVER SAW GANTRY PASS THROUGH THE TARGET POSITION WITHOUT HITTING THE PATIENT ON TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS 600C

    Patients

    Seq Age Sex Outcome Treatment
    1