BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMVIEW NT WITH IDI

    MDR report key: 3456084 · Received September 25, 2013

    Report

    Report Number
    2910081-2013-07739
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    KPQ
    PMA / PMN Number
    K953233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS U.S. BECAME AWARE OF THE REPORTED EVENT ON SEPTEMBER 2, 2013. THIS MDR IS BEING MAILED ON SEPTEMBER 24, 2013. SIEMENS' INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION. CUSTOMER ADDRESS: (B)(6). BRAND NAME: SIMVIEW NT, P/N 5496992 AND SIMVIEW NT WITH IDI, P/N 5497016 ARE BOTH AFFECTED PRODUCTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    SIEMENS U.S. WAS NOTIFIED ON SEPTEMBER 2, 2013 THAT DURING A SERVICE CALL ON (B)(4) 2013, SIEMENS' CUSTOMER SERVICE ENGINEER (CSE) ROTATED THE GANTRY BY USING THE HAND CONTROL. HOWEVER, WHEN THE BUTTON TO STOP ROTATION WAS PRESSED, THE MOTION SWITCH WAS RELEASED AND THE SAME COMMAND GIVEN ON THE TOUCH SCREEN, THE GANTRY ROTATION DID NOT STOP. REPORTEDLY, THE CSE PRESSED THE YELLOW EMERGENCY BUTTON AT THE HAND CONTROL BUT THE GANTRY ROTATION STILL DID NOT STOP. THEN, THE CSE TURNED OFF THE F1 FUSE TO DIS-ENERGIZE THE SYSTEM; HOWEVER, IT HAD ALREADY "CRASHED." THERE IS NO REPORT OF MISTREATMENT OR INJURY TO A PATIENT. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486520 SIMVIEW NT WITH IDI SYSTEM, SIMULATION, RADIATION THERAPY KPQ SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 05497016 NA

    Patients

    Seq Age Sex Outcome Treatment
    1