BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD-IMAGER

    MDR report key: 997881 · Received December 24, 2007

    Report

    Report Number
    2916710-2007-00008
    Event Type
    Malfunction
    Date Received
    December 24, 2007
    Date of Event
    July 29, 2007
    Report Date
    July 29, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE FROM SAME LOT OF THE ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. DEVICE EVALUATED WITH RESPECT TO OPERATIONAL ENVIRONMENT. VARIAN VERIFIED AND CONFIRMED THE PROBLEM USING A DEMO SYSTEM. RESULTS: THE IMAGE ORIENTATION TAG IN CBCT SLICES (DICOM EXPORT IN CBCT APPLICATION) ARE NOT SET APPROPRIATELY AND RESULT IN A FAILURE TO IMPORT CT SLICES IN ANY SYSTEM (E.G. ECLIPSE OR THIRD PARTY SYSTEMS). ONLY CT SCANS WITH A PT ORIENTATION HEAD FIRST - SUPINE (HFS) ARE IMPORTED CORRECTLY. BECAUSE OF THIS SOFTWARE ANOMALY, WHEN OTHER ORIENTATIONS ARE IMAGED, THE IMAGE WILL BE "MIRRORED" WHEN IMPORTED INTO ECLIPSE OR OTHER APPLICATIONS. IMPORT OF NON HFS CBCT SCANS INTO ANY PLANNING SYSTEM REFLECTS INCORRECT IMAGE ORIENTATION, (ROTATED OR MIRRORED VIEWS) WHICH MAY RESULT IN IMPROPER PLANNING AND LEAD TO A POTENTIAL MISADMINISTRATION. CONCLUSION: CUSTOMERS USING ON-BOARD-IMAGING FOR PLANNING WITH CBCT SCANS IS NOT AN INTENDED USE CASE. IF USED FOR PLANNING, THE COMPARISON OF A MIRRORED CBCT IMAGE FROM OBI VERSUS, A REFERENCE IMAGE SUCH AS CT SCAN WOULD IDENTIFY THE INCORRECT ORIENTATION. THEREFORE, THE SOFTWARE ANOMALY DOES NOT POSE A SIGNIFICANT HAZARD. HOWEVER, CUSTOMERS USING ACUITY, PLANNING WITH CBCT SCANS IS AN INTENDED USE CASE AND PRESENTS A POTENTIAL RISK FOR MISADMINISTRATION BECAUSE OF THE INCORRECT IMAGE ORIENTATION FOR NON-HFS SCANS. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER "IMPORTED A CBCT THAT WAS HFP. THE ORIENTATION LABELS ONCE IN ECLIPSE WERE ALL OK, BUT THE IMAGE APPEARED TO BE HFS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD-IMAGER ACCESSORY, MEDICAL LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other