BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2072559 · Received April 20, 2011

    Report

    Report Number
    2916710-2011-00040
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    August 17, 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, 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 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 2/23/2011, 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 3/22/2011, 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 FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY HAVE TAKEN MV IMAGES THAT ARE NOT SHOWING UP IN OLR. THEY SAVE IMAGES ON OBI AND THEY DO NOT GET ANY SAVE FAILED MESSAGES BUT THE IMAGES ARE NOT IN OLR. ALL IMAGES ARE MV IMAGES TAKEN WITH OBI AI 1.4.13.0. ACCORDING TO RT CHART HISTORY TAB THE PATIENT WAS IMAGED 21 TIMES ON (B)(6) 2009 ALL IN SESSION ONE. THE PATIENT WAS CLOSED AND LEFT ON THE QUEUE SO SESSION 1 REMAINED ACTIVE. THE PATIENT RETURNED TODAY (B)(6) 2009 AND THEY RESUMED IMAGING STILL IN SESSION 1. HOWEVER, AFTER TAKING AND SAVING SEVERAL IMAGES, THEY OPENED OLR AND DID NOT SEE THE IMAGES. THEY CLOSED THE PATIENT AT 4D, THEY DID NOT GET ANY SAVE ERRORS. THEY RELOADED IN OLR BUT STILL HAD NO IMAGES FOR TODAY. THEY RELOADED THE PATIENT AT 4D AND OBI, STILL IN SESSION 1 AND RESUMED FILMING. THE IMAGES TAKEN AFTER THIS POINT DID SHOW UP IN OLR REVIEW WITH TODAY'S DATE (B)(6) AND THE CORRECT TIME. IT APPEARS THAT SOME OF THE IMAGES TAKEN ON (B)(6) WERE SAVED WITH A TIME AND DATE OF (B)(6). 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. HRO

    Patients

    Seq Age Sex Outcome Treatment
    1