BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 3142285 · Received May 28, 2013

    Report

    Report Number
    2910081-2013-03845
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. - RADIATION ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K123812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMEN'S INVESTIGATION INTO THE REPORTED OCCURRENCE REVEALS THAT THE TABLE MOVEMENT HAPPENS DUE TO WORKFLOW ERRORS THAT OCCURS WHEN VARIAN TREATMENT IS CONNECTED TO SIEMENS ONCOR LINAC SYSTEMS. HOWEVER, SIEMENS LINAC SYSTEM OPERATED AS SPECIFIED ACCORDING TO THE TREATMENT INFORMATION RECEIVED FROM VARIAN TREATMENT AND (B)(4) 2.3.33. THE REPORTED INFORMATION HAS BEEN FORWARDED TO VARIAN FOR INVESTIGATION.

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED ON (B)(4) 2013 THAT THE VARIAN TREATMENT INTERFACE USED WITH RT THERAPIST (B)(4) 2.3.33 IN CONNECTION WITH THE ONCOR LINAC SYSTEM ALLOWED TREATMENT TABLE MOVEMENT AFTER THE FIRST SEGMENT FIELD WAS TREATED. REPORTEDLY, THE TREATMENT TABLE MOVEMENTS OCCURRED DURING AUTO FIELD SEQUENCING FOR THREE PTS THAT RESULTED IN MISTREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232891 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. - RADIATION ONCOLOGY 05857912 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 RT THERAPIST ((B)(4)) 2.3.33| VARIAN TREATMENT| ONCOR: SW VERSION 9.2.18