BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2133285 · Received May 12, 2011

    Report

    Report Number
    2916710-2011-00049
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NOT MISADMINISTRATION OR SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING TREATMENT PLANNING AND VERIFICATION ON THE FIRST DAY OF PT TREATMENT, THE FOLLOWING OCCURRED: FIELD 1= GANTRY 90 DEGREES AND COUCH (PAT. SUPPORT ANGLE) 355 DEGREES. MV IMAGING + TREATMENT OK. FIELD 2 = GANTRY 270 DEGREES AND COUCH 5 DEGREES. MANUALLY ROTATED THE GANTRY AND COUCH INSIDE TREATMENT ROOM. THE CUSTOMER MV IMAGED IN CLINICAL MODE THEN SCHEDULED IN RT CHART. THE 4DTC DIDN'T CHANGE COUCH ROTATION VALUE, IT WAS STILL ON 355 DEGREES AND HIGHLIGHTED. THE CUSTOMER ROTATED COUCH BACK TO 355 DEGREES, THE 4DTC WAS OK AND READY TO BEAM ON. THE CUSTOMER NOTICED THE WRONG COUCH ANGLE AND ROTATED THE COUCH BACK 5 DEGREES AND STILL SHOWED WRONG IN 4DTC. THE CUSTOMER TRIED TO CLEAR MODE UP AND MODE UP AGAIN TO SEE IF THE RIGHT COUCH ANGLE WOULD APPEAR BUT IT DID NOT. THE CUSTOMER CLOSED THE PT IN TREATMENT, THE PHYSICIST WAS CONTACTED AND THE PT WAS OPENED IN RT CHART TO VERIFY THE CORRECT COUCH ANGLE. COUCH ANGLE ACCORDING TO THE PLAN IN RT CHART WAS 5 DEGREES FOR FIELD 2. THE CUSTOMER REOPENED THE PT IN TREATMENT AND 4DTC NOW DISPLAYED CORRECTLY AT 5 DEGREES. THE CUSTOMER VERIFIED TREATMENT WITH MV IMAGING AND TREATED THE PT CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1