BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO RT THERAPIST 4.3.1_MR3

    MDR report key: 6121701 · Received November 22, 2016

    Report

    Report Number
    2240869-2016-59098
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K142434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED ISSUE IS ON-GOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. THIS INFORMATION HAS BEEN REQUESTED AND HAS NOT BEEN RECEIVED, TO DATE. CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED SIEMENS ON (B)(6) 2016 THAT PRIOR TO PATIENT POSITIONING, THERE WAS AN ISSUE WITH THE FULL TEXT OF SETUP INSTRUCTIONS NOT BEING FULLY VISIBLE ON THE IN-ROOM DISPLAY AFTER BEAMS WERE DOWNLOADED FROM RT THERAPIST TO THE CONTROL CONSOLE. REPORTEDLY, IF THE TEXT IS LONGER THAN WHAT THE SMALL DISPLAY CAN SHOW, THE USER CAN DOUBLE CLICK INSIDE THE TEXT BOX AND THIS WILL OPEN TO A FULL SCREEN. IF THE FULL TEXT IS STILL NOT SHOWN, A SCROLL BAR ALLOWS THE USER TO SCROLL DOWN TO SEE THE REMAINING TEXT. THE SCROLL BAR IN THE SMALL TEXT FIELD DISPLAYS THE BOTTOM LINE OF THE TEXT WHEN THE USER SCROLLS DOWN. WHEREAS, IN THE FULL SCREEN DISPLAY, WHEN THE USER SCROLLS COMPLETELY DOWN, THE LAST LINE OF SETUP INSTRUCTIONS IS MISSING. MISSING INFORMATION COULD LEAD TO INCORRECT POSITIONING FOR TREATMENT WITH A POSSIBILITY OF TREATMENT DOSE TO THE WRONG LOCATION. SIEMENS IS UNAWARE OF ANY INJURY OR MISTREATMENT TO A PATIENT. THIS REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771219 SYNGO RT THERAPIST 4.3.1_MR3 ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1