BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2090526 · Received April 19, 2011

    Report

    Report Number
    2916710-2011-00036
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    May 26, 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
    WA, US
    Reporter Occupation
    PHYSICIST

    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 PATIENT INSTEAD OF PRESSING 'SAVE IMAGE'. WHEN PATIENT 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 THE MOST RECENT COMPLAINT RECEIVED (B)(4) 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 (B)(4) 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 FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED WITH AN ISSUE WITH DOUBLE EXPOSURE MV IMAGING THAT DOES NOT SHOW IN OLR. SITE IS TAKING DOUBLE EXPOSURE MV IMAGES ON A CUBE TO CHECK LIGHT INCIDENCES. THEY WOULD TAKE BOTH IMAGES AND THE IMAGES WOULD APPEAR ON OBI SCREEN. THEY WOULD SELECT SAVE IMAGE AND THEN CLOSE OUT OF THE PATIENT. HOWEVER, WHEN THEY GO TO OLR SOMETIMES THE OPEN IMAGE WILL NOT SHOW AND ONLY THE PLANNED IMAGE SHOWS. CUSTOMER ALSO TESTED ON ANOTHER PLAN THAT IS A TEST PATIENT, AND AGAIN, WHEN TAKING DOUBLE EXPOSURE MV IMAGES, ONLY THE PLANNED IMAGE IS SUBSEQUENTLY SAVED BACK. CHECKED OLR TO SEE WHEN THE IMAGES WERE TAKEN AND TIME STAMP IS VISIBLE TO VERIFY THAT THE IMAGES WERE INDEED TAKEN, BOTH OPEN AND PLANNED IMAGES. 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 NONE IYE VARIAN MEDICAL SYSTEMS, INC. HRO

    Patients

    Seq Age Sex Outcome Treatment
    1