BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHERENCE THERAPIST

    MDR report key: 1191464 · Received September 19, 2008

    Report

    Report Number
    2910081-2008-00036
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 21, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - OTHER - INVESTIGATION IS CURRENTLY PENDING AND THE ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    WE HAVE BECOME AWARE OF A POTENTIAL ISSUE WITH OUR TREATMENT PLANNING/TREAT-STATION USED WITH OUR MEDICAL LINEAR ACCELERATOR. IT HAS COME TO OUR ATTENTION DURING PATIENT SETUP, THE OPERATOR NOTICED THAT THE CONE BEAM CONTOUR HAS BEEN ALTERED AND DOES NOT MATCH THE ORIGINAL STRUCTURE SET. THIS ISSUE CAN RESULT IN POTENTIAL MISTREATMENT OF THE OPERATOR IS NOT PAYING CLOSE ATTENTION TO THE CONTOUR SHIFT ON THE SYSTEM SCREEN. IT'S IMPORTANT TO NOTE, NO PATIENTS WERE MISTREATED AS A RESULT OF THIS ISSUE. THE CONTOUR SHOWS CORRECTLY IN OTHER RELATED WORKSTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENCE THERAPIST ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1