BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2072562 · Received April 20, 2011

    Report

    Report Number
    2916710-2011-00038
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    July 8, 2009
    Report Date
    March 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE "MV IMAGES HAVE WRONG DATE STAMP WHEN A COMMON CLINICAL WORKFLOW IS USED" IS A KNOWN ISSUE AND HAS BEEN TRACKED AND TRENDED SINCE MARCH OF 2009. CONSIDERED BY VARIAN AS NOT TO BE SIGNIFICANT SAFETY RISK, A WORKAROUND WAS IDENTIFIED FOR THIS ISSUE, SUCH THAT THE CUSTOMER SHOULD CLOSE THE PT INSTEAD OF PRESSING 'SAVE IMAGE'. WHEN PT IS CLOSED, IMAGE RECORDS ARE SAVED PRIOR TO THE IMAGE SAVE AND THEREFORE, THE IMAGE DAEMON WOULD NOT CHANGE THE CREATION DATE. IN 2009, A DISCREPANCY REPORT (DR) WAS LOGGED AND THE ISSUE FIXED IN THE VERSION 8.6.17 PRODUCTION RELEASE. THE ISSUE STILL EXISTS FOR CUSTOMERS WITH VERSIONS < 8.6.17. AS A RESULT OF THE MOST RECENT COMPLAINT RECEIVED 02/23/2011, VARIAN PERFORMED A NEW RISK HAZARD ANALYSIS (RHA), IN WHICH THE LATEST COMPLAINT AND TRENDING INFO WERE CONSIDERED AND EVALUATED. AS A RESULT OF THIS RHA, VARIAN DETERMINED ON 03/22/2011, THAT THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS HARM, AND HAS ISSUED A CAPA TO FURTHER ADDRESS THIS ISSUE FOR CUSTOMERS WITH VERSIONS <8.6.17. THIS REPORT IS A RESULT OF VARIAN'S RETROSPECTIVE REVIEW AND TRENDING DATA. ALL CORRECTIVE ACTION RELATED TO THIS MALFUNCTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    MV IMAGES IN OFFLINE REVIEW ARE DOCUMENTED ON THE INCORRECT DATE. I HAVE OBSERVED THAT 8 MV IMAGES ARE REPORTED ON (B)(6) 2009 IN RT CHART HISTORY, FOR SESSION 17. I HAVE OBSERVED THAT 13 MV IMAGES ARE RECORDED FOR (B)(6) 2009 IN OFFLINE REVIEW. INCLUDING A "CINE" IMAGE WHICH THE CUSTOMER DENIES TAKING. I HAVE OBSERVED THAT 7 MV IMAGES WERE RECORDED ON (B)(6) 2009 IN RT CHART HISTORY, FOR SESSION 17, ALSO. I HAVE OBSERVED THAT 2 MV IMAGES WERE RECORDED ON (B)(6) 2009 IN OFFLINE REVIEW. THIS PT DID NOT RECEIVE TREATMENT ON (B)(6), THESE WERE "IMAGE ONLY" SESSIONS. CUSTOMER CONFIRMS IMAGE DOCUMENTATION TO BE CORRECT IN RT CHART HISTORY WITH RESPECT TO DATE AND TIME, THIS DOES NOT CORRELATE IN OFFLINE REVIEW. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HIT

    Patients

    Seq Age Sex Outcome Treatment
    1