BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 2543069 · Received March 30, 2012

    Report

    Report Number
    2910081-2012-00026
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED OCCURRENCE ON (B)(4) 2012. THE SYNGO RT THERAPIST 4.2 SOFTWARE DOES NOT ALLOW SAVING CHANGES OF THE RT STRUCTURE OR PLANNING CT DATA, AND THIS IS DESCRIBED IN THE RT THERAPIST ONLINE GUIDE. HOWEVER, THE INCORRECT DESCRIPTION OF THIS WORKFLOW IS IN THE SYNGO RT THERAPIST QUICK GUIDE. CORRECTIVE ACTION IS BEING IMPLEMENTED TO CORRECT THE WORKFLOW DESCRIBED IN THE SYNGO RT THERAPIST QUICK GUIDE. PROPER TRAINING IS IN ORDER FOR THE USER. CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED VIA EMAIL BY THE CUSTOMER ON (B)(4) 2012, WHEN THEY WERE REVIEWING THE PLANNING CT IN THE ATISTE SYSTEM AFTER PERFORMING PRE-TREATMENT CHECKS ON THE PT, IT WAS NOTICED THAT THE INCORRECT REFERENCE POINT WAS "CHECKED" AS THE ISOCENTER. REPORTEDLY, WHILE THEY WERE ABLE TO "UNCHECK" THAT INCORRECT REFERENCE POINT AND "CHECK" THE CORRECT REFERENCE POINT, (B)(6) (MD) WOULD NOT ALLOW THEM TO SAVE THE CHANGE BECAUSE THE SAVE BUTTON WAS GREYED OUT. THERE IS NO REPORT OF MISTREATMENT OR INJURY TO A PT. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISTE MV SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 08139789 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL NO. (B)(4)| SYNGO RT THERAPIST, MODEL NO. 08162815,