BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4DITC - 4D INTERGRATED TREATMENT CONSOLE

    MDR report key: 1961442 · Received January 6, 2011

    Report

    Report Number
    2916710-2010-00153
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY IN THIS CASE. SHOULD THE WRONG WEDGE NOT BE DETECTED AND TREATMENT DELIVERED, THE ISSUE COULD LEAD TO A DOSE ERROR AND POTENTIALLY CAUSE A SERIOUS INJURY. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE 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

    CUSTOMER STATES THE WEDGE WAS LOADED WITH THE WRONG ORIENTATION BUT THE CLINAC AND 4DITC SYSTEMS DID NOT SHOW ANY FAULTS AND WOULD HAVE ALLOWED TREATMENT TO CONTINUE. THE CUSTOMER NOTICED THE ERROR AND CORRECTED THE WEDGE ORIENTATION BEFORE CONTINUING WITH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4DITC - 4D INTERGRATED TREATMENT CONSOLE TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS INC. MODEL: 8.8.1

    Patients

    Seq Age Sex Outcome Treatment
    1