BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2133293 · Received May 12, 2011

    Report

    Report Number
    2916710-2011-00048
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K862645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AFTER THE THERAPIST HAD POSITIONED THE PT IN TREATMENT ROOM AND CAME TO THE CONSOLE TO START THE TREATMENT, THE WEDGE SUDDENLY FELL TO THE FLOOR. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT BECAUSE THE PIN WAS NOT FULLY OUT, THE S1 SWITCH ACTUATED PARTIALLY, AND COMBINED WITH GANTRY AND COLLIMATOR POSITION, THE WEDGE FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H18

    Patients

    Seq Age Sex Outcome Treatment
    1