BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR EXPRESSION W/COHERENCE THERAPIST

    MDR report key: 961551 · Received December 6, 2007

    Report

    Report Number
    2910081-2007-00035
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    August 10, 2007
    Report Date
    November 2, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS, ONCOLOGY CARE SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ATTACHMENT TITLED ADDITIONAL MFR'S NARRATIVE MDR 2910081-2007-00035. THIS REPORT SUMMARIZES THIS ISSUE AND INCLUDES OUR RISK ANALYSIS RESULT AND CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IN THE ABUNDANCE OF CAUTION, THIS ISSUE IS BEING REPORTED: SYSTEMS INVOLVED: COHERENCE THERAPIST WORKSPACE (RTT VERSION 2.1) WHEN THE REFERENCE IMAGE HAS BEEN CALIBRATED FOR CENTERING, WHEN THE REFERENCE IMAGE IS USED FOR PT POSITIONING, THE IMAGE WILL SHIFT WHEN THE POSITIONING TOOLS ARE USED. POTENTIAL FOR MISTREATMENT IF THE IMAGE IS SHIFTED SO THAT THE IMAGE ISOCENTER DOES NOT CORRESPOND TO THE MACHINE ISOCENTER. ITS IMPORTANT TO NOTE THAT THE ANOMALY WAS DISCOVERED PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR EXPRESSION W/COHERENCE THERAPIST ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS, ONCOLOGY CARE SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR