BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2143582 · Received June 3, 2011

    Report

    Report Number
    2916710-2011-00065
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VARIAN EMPLOYEE HAS REPORTED THAT THE GANTRY PRO READOUT CAN BE CALIBRATED IN REVERSE ON THE CLINAC C-SERIES PRODUCT LINE. THERE HAVE BEEN NO REPORTED OCCURRENCES OF THIS ISSUE; HOWEVER, IT IS REPORTED TO BE POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1