BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2072560 · Received April 20, 2011

    Report

    Report Number
    2916710-2011-00041
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    September 14, 2009
    Report Date
    March 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 A 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 DAMEON 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 THIS MOST RECENT COMPLAINT REC'D ON 02/23/2011, VARIAN PERFORMED A NEW RISK HAZARD ANALYSIS (RHA), IN WHICH THE LATEST COMPLAINT AND TRENDING INFORMATION 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. 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

    CUSTOMER REPORTS: IMAGES ACQUIRED ON (B)(6) 2009. NO TREATMENT (B)(6) 2009 - IMAGES ACQUIRED AND PT TREATED. ALL IMAGES ARE SAVING BACK TO OLR WITH WRONG TIME STAMP. RTC HISTORY SHOWS 2 IMAGES TAKEN ON (B)(6). THERE WERE ALSO 2 IMAGES ACQUIRED ON (B)(6). OLR - SHOWS IMAGES SAVED BACK ON THE (B)(6) 2009 SESSION EVEN THOUGH ADDITIONAL IMAGES ACQUIRED ON THE (B)(6) 2009 WITH TREATMENT. THERE WAS NO SERIOUS INJURY REPORTED 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 HRO

    Patients

    Seq Age Sex Outcome Treatment
    1