BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RPM RESPIRATORY GATING

    MDR report key: 2000507 · Received February 1, 2011

    Report

    Report Number
    2916710-2011-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K063270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATOR FOR THIS COMPLAINT HAS REPORTED THAT THIS IS A KNOWN ISSUE PREVIOUSLY INVESTIGATED AND REPORTED. A DISCREPANCY REPORT HAS BEEN CREATED FOR THE ISSUE FIX AND RETROFIT OF THE INSTALL BASE. THE ERROR MAY BE REPRODUCED WITH RPM 1.7.5 3D IF THE SYSTEM IS INDUCED TO FREQUENTLY LOSE AND RE-ACQUIRE TRACKING OF THE 6-DOT MARKER BLOCK. THE ROOT CAUSE OF THE MALFUNCTION HAS BEEN DETERMINED TO LIE WITHIN THE SMART TRACK SOFTWARE LIBRARY USED ONLY BY THE RPM 1.7. 3D VERSION (2D TRACKING IS NOT AFFECTED). A CUSTOMER TECHNICAL BULLETIN HAS BEEN CREATED TO INFORM THE CUSTOMER ABOUT THIS ISSUE AND THE PRODUCT FIX. THERE WAS NO ADVERSE EVENT AS A RESULT OF THIS COMPLAINT. SHOULD THIS MALFUNCTION RECUR, IT IS IMPOSSIBLE THAT IT WOULD RESULT IN SERIOUS INJURY. NO ADD'L F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    WHILE DEMONSTRATING AND TRAINING THE RPM PRODUCT, THE STAFF AND THE VARIAN TRAINER (VT) NOTICED THAT THE SINE WAVE TRACING BECAME INVERTED; THE WORKSTATION WAS CLOSED AND THE PT WAS BROUGHT BACK UP TO CHECK TO SEE IF IT WAS JUST A DISPLAY ISSUE, AND AGAIN THE TRACING WAS INVERTED. THERE WAS NO ADVERSE EVENT AS A RESULT OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RPM RESPIRATORY GATING ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS H50

    Patients

    Seq Age Sex Outcome Treatment
    1