BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CONEBEAM COMPUTED TOMOGRAPHY

    MDR report key: 991392 · Received February 1, 2008

    Report

    Report Number
    8020711-2007-00011
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    October 10, 2007
    Report Date
    October 10, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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 FROM 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. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    A VARIAN CUSTOMER REPORTS "WHEN ANY PT POSITION OTHER THAN HEAD-FIRST SUPINE (HFS) IS ENTERED, THE RESULTING CT RECONSTRUCTION IS ERRONEOUSLY MIRRORED LEADING TO POTENTIAL MISTREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CONEBEAM COMPUTED TOMOGRAPHY ACUITY CBCT KPQ VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other