BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1942406 · Received December 20, 2010

    Report

    Report Number
    2916710-2010-00146
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 26, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K050479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS DETERIORATION IN STATE OF HEALTH IS REPORTED. THE PHYSICIST REPORTED CRITICAL ORGANS WERE NOT IRRADIATED DURING THE OCCURRENCE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE SELECTED THE "OVERRIDE ALL" AT THE 4DTC WORKSTATION BUT DID NOT VERIFY THE RESULTS. THE GANTRY ANGLE, COLLIMATOR ANGLE, JAW POSITION WAS NOT COMPLETELY WHERE IT SHOULD HAVE BEEN. THE PT WAS POSITIONED ON THE TABLE AND THE TREATMENT WAS STARTED. THE PT WAS DELIVERED 42 MUS BEFORE HOSPITAL STAFF REALIZED THAT THE POSITION WAS NOT CORRECT. THE TREATMENT WAS STOPPED IMMEDIATELY. ACCORDING TO THE HOSPITAL PHYSICIST, CRITICAL ORGANS WERE NOT IRRADIATED DURING THE OCCURRENCE. AFTER INVESTIGATION BY THE HOSPITAL STAFF ON SITE, THE HOSPITAL PHYSICIST INFORMED VARIAN OF THIS INCIDENT AS A COURTESY. NO OTHER PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE LINEAR ACCELERATOR SOFTWARE IYE VARIAN MEDICAL SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1