BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RPM RESPIRATORY GATING SYSTEM

    MDR report key: 3130097 · Received May 21, 2013

    Report

    Report Number
    2916710-2013-00011
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K063270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MOR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIST AT AN INSTITUTION THAT USES PHASE AND AMPLITUDE GATING IN THEIR SBRT PROGRAM HAS BEEN PERFORMING EXTENSIVE ANALYSIS OF THE DATA BEING GENERATED BY THE RPM RESPIRATORY GATING SYSTEM DURING TREATMENT OF LUNG PATIENTS WHO ARE BEING TREATED WITH RPM. THE RPM DATA IS EXPORTED AND THE PHYSICIST HAS USED THE EXPORTED DATA TO ANALYZE THE RPM BEHAVIOR STATING THAT THE RPM PHASE RESULTS DIFFER DRAMATICALLY DEPENDING UPON THE "LEARNING PHASE". THE PHYSICIST HAS MADE MANY ANALYSES OF THE RPM RESULTS, SHOWING THE DIFFERENCES USING AMPLITUDE VERSUS PHASE PLOTS. ACCORDING TO THE PHYSICIST, THE RPM RESULTS DIFFER DRAMATICALLY IN THE AMPLITUDE VERSUS PHASE PLOTS DEPENDING UPON THE "LEARNING PHASE". THE SAME PATIENT WILL HAVE DRAMATICALLY DIFFERENT AMPLITUDE VERSUS PHASE PLOTS IF THE "LEARNING PHASE" IS REPEATED. THE PHYSICIST HAS SEEN THIS SEVERAL PATIENTS AND IS ABLE TO REPRODUCE EXPECTED AND UNEXPECTED RESULTS MERELY BY "RELEARNING" THE BREATHING PATTERN, STATING THAT HE HAS TO PAY ATTENTION TO ENSURE THAT THE DESIRED RPM PHASE PATTERN IS OBSERVED. THE PHYSICIST NOTICED THIS BEHAVIOR ON THE FIRST SBRT PATIENT BEING TREATED AT THE INSTITUTE AND CORRECTED THE BEHAVIOR BEFORE CONTINUING WITH THE TREATMENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226185 RPM RESPIRATORY GATING SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H50

    Patients

    Seq Age Sex Outcome Treatment
    1