BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2090523 · Received April 19, 2011

    Report

    Report Number
    2916710-2011-00035
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 25, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 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

    THE CUSTOMER STATES THEY ARE UNABLE TO EXPORT IMAGES TO (B)(4) WHICH THEIR THIRD PARTY IMAGING VIEWING SOFTWARE LIKE OFFLINE REVIEW. THE IMAGES ARE EXPORTED WITH THE SAME DATE AND TIME FOR THE FOLLOWING SCENARIOS. A DOUBLE EXPOSURE - THE OPEN AND CLOSED IMAGES HAVE THE EXACT SAME CREATION DATE AND TIME. AN IMAGE WAS TAKEN THE DAY BEFORE THE FIRST TREATMENT. ON THE SECOND DAY, THE SAME SESSION WAS IMAGED AND TREATED. THE IMAGES TAKEN ON DAY TWO HAVE THE EXACT SAME CREATION DATE AND TIME AS DAY ONE IMAGES. THE CUSTOMER REPORTED THAT THEY HAD TO SEND A PT HOME UNTIL THEY COULD SORT OUT WHICH IMAGE IS ASSOCIATED TO WHICH PLAN FOR A PT THAT RECEIVED OVER 20 IMAGES. THIS IS AFFECTING THE PROCESS AT SITE. THERE WAS NO REPORT OF 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