BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMVIEW 3000

    MDR report key: 1032417 · Received April 15, 2008

    Report

    Report Number
    2910081-2008-00023
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 19, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    KPQ
    PMA / PMN Number
    K946053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION, AND THE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    WE HAVE BECOME AWARE OF A PRODUCTION ISSUE WITH OUR RADIATION THERAPY SIMULATION SYSTEM. DURING THE 'DISMOUNT' FUNCTION, WITH THE GANTRY SLIGHTLY ROTATED COUNTER CLOCKWISE, THE SIMULATION TABLE CAME DOWN VERTICALLY FIRST AND COLLIDED WITH THE IMAGE INTENSIFIER'S CASSETTE HOLDER. NO PT WAS INJURED AS A RESULT OF THIS INCIDENT. NORMALLY BEFORE TABLE VERTICAL MOVEMENT, THE IMAGE INTENSIFIER SHOULD HAVE MOVED TOWARD THE GANTRY SO THAT THE COLLISION SHOULD NOT BE POSSIBLE. THE CUSTOMER DID NOT RECORD THE EXACT POSITION OF THE TABLE OR GANTRY, SO THE SITE SERVICE ENGINEER WAS NOT ABLE TO DUPLICATE THE INCIDENT. IT IS IMPORTANT TO NOTE, THAT DURING SUCH AUTO-SET, THE OPERATOR IS PRESSING THE ENABLE MOTION SWITCH AND CAN INTERRUPT THE MOTION AT ANY TIME. INVESTIGATION IS CURRENTLY ONGOING AND THE ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMVIEW 3000 SYSTEM, SIMULATION, RADIATION THERAPY KPQ SIEMENS MEDICAL SOLUTIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1