BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORVUS

    MDR report key: 666421 · Received January 11, 2006

    Report

    Report Number
    2434141-2006-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2006
    Date of Event
    December 2, 2005
    Report Date
    January 9, 2006
    Manufacturer
    NOMOS CORP.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN TRANSFERRING DIGITALLY RECONSTRUCTED RADIOGRAPHS (DRR'S) TO A VARIS RECORD AND VERIFY SYSTEM, THE DRR IMAGES WERE DISTORTED WHEN DISPLAYED ON VARIS. THE SYSTEM DID NOT DISPLAY AN ERROR MESSAGE, BUT THE DISTORTION WAS DETECTED BY THE USER. THE IMAGES WERE NOT UTILIZED FOR TREATMENT. A BULLETIN WAS SENT TO CUSTOMERS. THE ISSUE HAS BEEN CORRECTED IN CORVUS 6.2. THE POSSIBLE POSITIONING ERRORS ARE PROPORTIONAL TO THE AMOUNT OF DISTORTION OF THE IMAGE. FOR THE POSITIONING ERROR TO BE SIGNIFICANT THE DISTORTION OF THE IMAGE WOULD ALSO BE SIGNIFICANT AS COMPARED TO THE PORT FILM. NOTE ALSO THAT THE IMAGES WILL BE DISPLAYED CORRECTLY IN CORVUS. THIS ISSUE AFFECTS CORVUS 6.0 AND 6.1 WITH PT PLANS USING TREATMENT UNITS THAT HAVE NON-SQUARE PENCIL BEAMS. THIS ISSUE MAY EXHIBIT ITSELF IN THE FOLLOWING WAYS: AN ERROR IN THE SYSTEM IMPORTING THE DICOM DRR STATING THAT THE DRR CANNOT BE IMPORTED. THIS WOULD PREVENT THE IMPORTING SYSTEM FROM READING THE DICOM DRR SENT FROM CORVUS. THE DRR VIEWED IN THE SYSTEM IMPORTING THE DICOM DRR MAY APPEAR DISTORTED. ANY ANNOTATIONS DISPLAYED ON THE DICOM DRR MAY APPEAR SLIGHTLY SHIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORVUS RADIATION THERAPY PLANNING SYSTEM MUJ NOMOS CORP. CORVUS 6.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *