BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY WITH MIRS

    MDR report key: 2003115 · Received January 4, 2011

    Report

    Report Number
    2916710-2010-00151
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 7, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORT INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED AN MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CONCURRENT EDITING/ACCESS ISSUES: PT TREATMENT PLAN REVISION PERFORMED IN ARIA RT CHART WHILE PT WAS BEING TREATED. CUSTOMER SAID THEY SAW NO WARNING AND SYSTEM DID NOT PREVENT AN EDIT DURING TREATMENT. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY WITH MIRS RADIATION ONC MGT SYS IYE VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS HRO

    Patients

    Seq Age Sex Outcome Treatment
    1