BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR EXPRESSION WITH COHERENCE THERAPIST 2.1

    MDR report key: 946645 · Received November 7, 2007

    Report

    Report Number
    2910081-2007-00032
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 2, 2007
    Report Date
    November 5, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS, ONCOLOGY CARE SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SHOWS THAT THE ROOT CAUSE IS THAT THE DRR IS NOT SQUARE, I.E. 256X256, OR 512X512 PIXELS. THIS IS A VARIATION OF THIS IMAGE SHIFT OCCURRENCE THAT HAS BEEN PREVIOUSLY REPORTED UNDER MDR 2910081-2007-00031. A CUSTOMER SAFETY ADVISORY NOTICE, DATED OCTOBER 03, 2007, DOCUMENT # T2-00. 6800.02.01.02, HAS BEEN RELEASED TO ALL CUSTOMERS WITH COHERENCE THERAPIST R2.1 AND PRIMEVIEW 3I, R2.1 WORKSPACES. THIS ADVISORY LETTER IS RELEASED. SOFTWARE UPDATE TO REPAIR THIS DEFECT IS IN PROGRESS.

    Description of Event or Problem · 1

    IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED TO THE FDA. CUSTOMER NARRATIVE: WE ACQUIRED A P.I. (PORTAL IMAGE), DRR (DIGITALLY RECONSTRUCTED RADIOGRAPH) IS LOADED AND ASSOCIATED AUTOMATICALLY. WHEN WE TRY TO DRAW SOMETHING ON THE DRR (USING THE PENCIL TOOL), THEN THE DRR CHANGES THE WINDOWING AND IS SHIFTED "DOWN" ... IN CASE OF AN AP FIELD, THE SHIFT IS LONGITUDINAL. THE SITUATION IS OBVIOUS THAT THE CUSTOMER CANNOT CALCULATE OFFSET. ISSUE WAS DISCOVERED DURING APPLICATIONS TRAINING, NO PT INVOLVEMENT. POTENTIAL FOR MISTREATMENT IF THE PLANNING IMAGE IS SHIFTED SO THAT THE IMAGE ISOCENTER DOES NOT CORRESPOND TO THE MACHINE ISOCENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR EXPRESSION WITH COHERENCE THERAPIST 2.1 LINEAR ACCELERATOR IYE SIEMENS MEDICAL SOLUTIONS, ONCOLOGY CARE SYSTEMS R2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR