BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGNRT

    MDR report key: 5249571 · Received November 19, 2015

    Report

    Report Number
    3004832819-2015-00001
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    October 21, 2015
    Report Date
    November 18, 2015
    Manufacturer
    VISION RT LIMITED
    Product Code
    IWE
    PMA / PMN Number
    K123371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE ISSUE IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    THERE ARE NO REPORTS OF ANY PATIENT OR USER HARM RELATED TO THIS ISSUE. ALIGNRT (AND GATERT) CAN BE INTERFACED TO GATE THE TREATMENT BEAM ON SIEMENS LINACS. WHILST CONNECTED TO A SIEMENS LINAC, FOR REASONS STILL UNDER INVESTIGATION THE ALIGNRT SYSTEM MAY REPORT THE FOLLOWING WARNING MESSAGE DURING A PERIOD OF BEAM-HOLDING DUE TO THE PATIENT BEING OUT OF POSITION: "LINAC BEAM STATUS IS NOT AS SET. HOLD THE BEAM FROM THE LINAC CONSOLE. GATING HAS BEEN DISABLED. RESTART ALIGNRT TO ENABLE GATING". WHILE THE WARNING MESSAGE IS DISPLAYED AND FROM THIS POINT ONWARDS, THE ALIGNRT SYSTEM MAY ALLOW THE BEAM ON THE LINAC TO BE ENABLED INDEPENDENTLY OF THE PATIENT POSITION. THIS OCCURRED ONLY AT ONE CUSTOMER'S SITE. THE CUSTOMER CONFIRMED THAT THE ISSUE WAS PROMPTLY IDENTIFIED AND THAT NO PATIENT HARM OCCURRED. THERE ARE NO REPORTS OF A SIMILAR ISSUE HAVING OCCURRED AT OTHER SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766215 ALIGNRT PATIENT POSITIONING SYSTEM IWE VISION RT LIMITED ALIGNRT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK