BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RPM RESPIRATORY GATING SYSTEM

    MDR report key: 1944698 · Received December 9, 2010

    Report

    Report Number
    2916710-2010-00139
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 11, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K063270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS EVENT, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    "PT WAS ON THE TABLE FOR A SECOND TREATMENT. A NEW SESSION WAS CREATED AND SELECTED (AS WE HAVE HAD PROBLEMS IMPORTING THE OLD MOTION FILES INTO THE RPM WORKSTATION). THE GATING WAS SET TO 30% TO 70% (WHERE THE DIAL IS DASHED AT THE BOTTOM) JUST LIKE I DID THE NIGHT BEFORE. I HIT TRACK AND THEN ONCE THE TRACKING WAS OK, I HIT RECORD. I STARTED THIS PROCESS BEFORE THE FIRST CBCT, BUT THERE ENDED UP BEING MORE THAN ONE CBCT, SO WHEN I WENT TO GATE THE PT, I ENCOUNTERED AN ERROR AND THE PROGRAM CRASHED. I REOPENED THE SOFTWARE AND REPEATED THE STEPS. THIS TIME, WHEN THE RADIOPAQUE MARKER WENT UP, THE TRACKING LINE WENT DOWN. THIS WOULD HAVE GATED THE WRONG PART OF THE BREATHING CYCLE, EVEN THOUGH THE PARAMETERS WERE SET CORRECTLY. I CLOSED THE APPLICATION, REOPENED IT AND RESET THE PARAMETERS AND THE PROBLEM WAS FIXED." THE PHYSICIST OBSERVED THE GATING TRACKING INCORRECTLY ONLY WITH THIS ONE PT. THE ERROR WAS CAUGHT BEFORE PT WAS TREATED. SITE BACKED OUT OF THE APPLICATION AND RE-LAUNCHED WITH NO PROBLEMS OR ERRORS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1