BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATERT

    MDR report key: 5433871 · Received February 9, 2016

    Report

    Report Number
    3004832819-2016-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    January 7, 2016
    Report Date
    February 5, 2016
    Manufacturer
    ION RT LTD., VISION RT LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K072171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE ISSUE IS STILL IN PROGRESS.,

    Description of Event or Problem · 1

    WHEN USING PHASE-BASED GATING IN GATERT, THE EXPECTED BEHAVIOR IS THAT THE BEAM IS ENABLED IN THE INTERVAL SPECIFIED BY THE USER BETWEEN PHASE TAGS WHICH HAVE BEEN CORRECTLY IDENTIFIED. HOWEVER, IT HAS BEEN OBSERVED THAT IRREGULAR BREATHING MAY CAUSE THE SOFTWARE TO INCORRECTLY ASSIGN PHASE TAGS TO THE BREATHING SIGNAL AND THUS, UNDER SPECIFIC CONDITIONS, GATING MAY OCCUR AT INCORRECT PORTIONS OF THE BREATHING CYCLE. THEREFORE, THE ACTUAL BEHAVIOR IS THAT THE BEAM MAY BE ENABLED IN THE INTERVAL SPECIFIED BY THE USER BETWEEN PHASE TAGS WHICH, FROM TIME TO TIME, MAY BE INCORRECTLY IDENTIFIED. THIS WOULD RESULT IN ENABLING THE BEAM FOR PHASES OF THE BREATHING CYCLE NOT DEFINED B Y THE USER. IT SHOULD BE NOTED THAT THE ACTUAL BEAM STATUS IS CORRECTLY DISPLAYED ON THE SOFTWARE SCREEN. THE EXISTING "ABNORMAL BREATHING DETECTION" FUNCTION DETECTS ABNORMAL BREATHING, WHICH IN TURN PREVENTS THE BEAM TO BE ENABLED DURING SUCH CIRCUMSTANCES. ADDITIONALLY, THE "LIMITING REGIONS" FUNCTION FURTHER REDUCES THE LIKELIHOOD THAT THE POTENTIAL ISSUE MAY HAVE A CLINICAL IMPACT. THE USE OF THESE FUNCTIONS (WHICH ARE NOT PRESENT IN ALL DEVICES IN THE FIELD ) IS ALREADY DESCRIBED IN THE CURRENT GATERT USER GUIDE. THERE ARE NO REPORTS OF ANY PATIENT OR USER HARM RELATED TO THIS ISSUE. THE ISSUE WAS IDENTIFIED DURING TESTING, AND NOT IN CLINICAL USE OF THE DEVICE. THERE ARE NO REPORTS OF THE ISSUE HAVING OCCURRED IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81589 GATERT GATERT PATIENT POSITIONING SYSTEM IYE ION RT LTD., VISION RT LIMITED GATERT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA