BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMVIEW 3000 SIMULATOR

    MDR report key: 2443390 · Received January 19, 2012

    Report

    Report Number
    2910081-2012-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    KPQ
    PMA / PMN Number
    K946053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED EVENT ON (B)(4) 2011 AND ARE MAILING THE MDR ON (B)(4) 2012. SIEMENS CUSTOMER SERVICE ENGINEER FOUND DURING EVALUATION THAT THE MAIN CHAIN FOR THE MOTOR AND THE LIFTING SCREW OR BARRING WERE BOTH BROKEN. THE BROKEN CHAIN WAS REPLACED, AND A NEW TABLE BASE AND TABLE CABLE WERE INSTALLED. THE SIMULATOR IS BACK IN USE BY THE CUSTOMER. (B)(6).

    Description of Event or Problem · 1

    SIEMENS RECEIVED A REPORT ON (B)(6) 2011, NOTING THAT WHEN THE OPERATOR MOVED THE TABLE DOWN AT THE END OF A PATIENT'S SIMULATION SESSION ON THE SIMVIEW 3000 SIMULATOR, THE TABLE RAPIDLY FELL DOWN ABOUT 50 CM WITH THE PATIENT ON TOP OF IT. REPORTEDLY, THE PATIENT WAS NOT INJURED. THE PATIENT CAME DOWN FROM THE TABLE AND WENT OUT OF THE ROOM ON HIS OWN. SINCE THAT TIME THE TABLE DID NOT MOVE IN THE VERTICAL DIRECTION. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMVIEW 3000 SIMULATOR SYSTEM, SIMULATION, RADIATION THERAPY KPQ SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 01957153 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TABLE