BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR AVANT-GARDE

    MDR report key: 1001293 · Received February 19, 2008

    Report

    Report Number
    2910081-2008-00012
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 30, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON GOING AND THE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT IS BEING REPORTED IN ABUNDANCE OF CAUTION. A PRODUCT DEFECT WAS REPORTED WITH OUR MEDICAL LINEAR ACCELERATOR. DURING TREATMENT SETUP AND WHEN ANOTHER PART OF THE DEVICE (SUCH AS THE GANTRY) IS ENABLED TO MOVE MANUALLY FROM THE CONTROL CONSOLE, THE OPERATOR NOTICED THAT AN UNEXPECTED COLLIMATOR ROTATION IS OBSERVED. IT IS IMPORTANT TO NOTE, WHEN THE OPERATOR RELEASES THE MOTION ENABLE BUTTONS, THE COLLIMATOR ROTATION MOTION WILL STOP. IF AN ACCESSORY; SUCH AS A MICRO MULTI-COLLIMATOR, IS MOUNTED IN THE COLLIMATOR ACCESSORY HOLDER, AND ROTATES UNEXPECTEDLY, A COLLISION WITH THE PATIENT IS POSSIBLE AND POTENTIALLY RESULTING IN AN INJURY. THE INVESTIGATION IS ON GOING AND THE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1