BEUDAMED
    FDA Adverse Event Summary report: N

    SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2

    MDR report key: 3032822 · Received April 3, 2013

    Report

    Report Number
    2910081-2013-02111
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K102671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED OCCURRENCE HAS REVEALED THAT THE REPORTED BEHAVIOR IS VALID FOR ALL RT THERAPIST SYSTEMS. THE WORKFLOW DESCRIBED FOR THE REPORTED OCCURRENCE WAS NEVER TESTED BY SIEMENS PRIOR TO THIS REPORT THEREFORE THERE ARE NO TEST CASES AVAILABLE TO VALIDATE THE WORKFLOW DESCRIBED.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS ON (B)(6) 2013 THAT IT IS NOT POSSIBLE TO SAFELY TREAT A PATIENT ON TWO DIFFERENT LINAC MACHINES THAT ARE BOTH CONNECTED TO RTT 4.2. REPORTEDLY, THE CUSTOMER LOADED THE PATIENT TREATMENT PLAN TO LINAC 1, MADE SOME CHANGES AND TREATED THE PATIENT. ON THE NEXT DAY THE CUSTOMER COPIED ALL OF THE DATA ONTO THE RTT OF LINAC 2, MADE MORE CHANGES IN "WORKFLOW EDIT" AND TREATED THE PATIENT ON LINAC 2. ON DAY 3, THE CUSTOMER AGAIN COPIED ALL OF THE DATA FROM LINAC 2 TO LINAC 1. THE CUSTOMER THEN OPENED THE PATIENT DATA IN RTT ON LINAC 1, AND THE CHANGES THAT WERE MADE THE DAY BEFORE ON LINAC 2 COULD NOT BE FOUND AS THE PLAN UID WAS NOT CHANGED DURING THE MODIFICATION. IT IS ALSO REPORTED THAT THERE IS NO WARNING THAT PLAN MODIFICATIONS MIGHT BE DELETED AND MAY HAVE TO BE SET AGAIN. 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
    137234 SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 08162815

    Patients

    Seq Age Sex Outcome Treatment
    1 SW VERSION 4.2.108