BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 2078890 · Received April 25, 2011

    Report

    Report Number
    2910081-2011-00016
    Event Type
    Other
    Date Received
    April 25, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT INDICATES: THERE WERE TWO SCENARIOS REVIEWED AS PART OF THE RISK ANALYSIS. SEVERITY: 3 (SERIOUS). THERE HAS BEEN NO INJURY REPORTED. THE FPP COLLIDED WITH THE TABLE. THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY. PROBABILITY: PRELIMINARY B (IMPROBABLE). THE MINIMUM DISTANCE OF THE FPP DURING GANTRY ROTATION HAS BEEN REDUCED INTENTIONALLY BY A SW UPDATE. THIS MAY CAUSE COLLISIONS AS THE THERAPISTS ARE STILL USED TO THE LARGER DISTANCE FROM PREVIOUS SW VERSIONS. THE NEW MINIMUM DISTANCE IS THE SAME AS THE ONE USED FOR CBCT ALREADY BEFORE. THE FPP IS EQUIPPED WITH A TOUCH GUARD THAT WILL STOP THE MOTION IN CASE OF A COLLISION. CORRECTIVE ACTION IS PENDING FURTHER INVESTIGATION. NO OTHER PRODUCT IS CONCERNED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED WITH OUR ONCOR IMPRESSION PLUS LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. OUR CUSTOMER'S TREATMENT STAFF REPORTED THE FLAT PANEL IMAGER DID NOT MOVE TO ITS SAFE SOURCE-TO-IMAGE DISTANCE (SID) PRIOR TO A GANTRY MOVEMENT CAUSING THE PANEL TO COLLIDE WITH THE TABLE. FURTHER INVESTIGATION FOR CORRECTIVE ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1