BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION

    MDR report key: 779156 · Received August 31, 2006

    Report

    Report Number
    2910081-2006-00011
    Event Type
    Malfunction
    Date Received
    August 31, 2006
    Date of Event
    August 18, 2006
    Report Date
    August 18, 2006
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    k031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CUSTOMER TRAINING, A SIEMENS APPLICATIONS SPECIALIST EXTENDED THE FLAT PANEL IMAGING DEVICE (FPP) USING THE MOTION ENABLE SWITCHES. THE FPP REPORTEDLY STOPPED MOVING AND THEREFORE THE OPERATOR RELEASED THE MOTION ENABLE SWITCHES. BEFORE THE OPERATOR COULD DEPRESS THESE SWITCHES AGAIN TO ATTEMPT TO RE-INITIATE THE MOVEMENT, THE FPP REPORTEDLY MOVED WITHOUT ANY COMMAND FROM THE OPERATOR. THE INVESTIGATION SHOWED THAT THIS ISSUE OCCURRED DUE TO A TIMING ERROR IN THE MOTION ENABLE SWITCHES. AN UPDATE TO RESOLVE THIS ISSUE IS CURRENTLY UNDER DEVELOPMENT. IT IS IMPORTANT TO NOTE THAT THE RED EMERGENCY STOP BUTTON THAT STOPS ALL SYSTEM MOVEMENT REMAINS FUNCTIONAL IF THIS ISSUE OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 07337699 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *