BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGUIDE SYSTEM

    MDR report key: 3748170 · Received April 14, 2014

    Report

    Report Number
    9710332-2014-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    IYE
    PMA / PMN Number
    K072079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK ASSESSMENT WAS CONDUCTED BY THE MANUFACTURER AND THE RESULT WAS WITHIN THE TOLERABLE REGION. THE TECHNICAL INVESTIGATION DISCOVERED A SOFTWARE BUG AS CAUSE FOR THE PROBLEM. IT WAS FOUND THAT THE REPORTED INCIDENT ONLY OCCURS, WHEN A CERTAIN WORKFLOW IS CONDUCTED, BUT HAS PROVEN REPRODUCIBLE AND MAY OCCUR AGAIN IN FUTURE. FOR THE INCIDENT TO OCCUR, A PARTICULAR DEVIATION FROM THE STANDARD CLINICAL WORKFLOW IS A PREREQUISITE. THE DESCRIBED ERROR CAN BE CLASSIFIED AS A SLEEPING ERROR. THE SOFTWARE BUG HAS THE EFFECT THAT THE TREATMENT INHIBITION (EXTERNAL INHIBIT) IS NOT AVAILABLE DURING IRRADIATION AND THUS THERE IS NO MEANS TO STOP IRRADIATION AUTOMATICALLY, IN CASE OF UNINTENDED TABLE MOVEMENTS DURING TREATMENT. THE ABSENCE OF A WORKING TREATMENT INHIBITION ALONE DOES NOT CAUSE A HARM, BUT MAY CONTRIBUTE TO PATIENT INJURY IN CASE THE TABLE IS MOVED DURING IRRADIATION IS ON. IGUIDE VERSION (B)(4) IS AFFECTED. THE SOFTWARE BUG WILL BE FIXED IN THE NEXT RELEASE AND AN IMPORTANT USER NOTICE WILL BE ISSUED TO CUSTOMERS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS REASSESSED THIS CASE AND CONCLUDED THAT THE RISK IS WITHIN THE UNDESIRABLE REGION. A FIELD SAFETY CORRECTIVE ACTION WILL BE RELEASED ((B)(4)) AND A PATCH IS BEING DEVELOPED TO CORRECT THE BEHAVIOR OF THE IGUIDE SOFTWARE AND WILL BE RELEASED AS AN IMPORTANT FIELD SAFETY MODIFICATION." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM IS NOT OPERATING AS INTENDED. THE IGUIDE /HEXAPOD SYSTEM IS OPERATIONAL WHILE KEY IS IN OFF/3 O'CLOCK POSITION. IGUIDE CANNOT RAISE THE EXTERNAL INHIBIT IF KEY IS IN 3 O'CLOCK POSITION. THIS MAY MISLEAD THE USER INTO FALSE SECURITY - ASSUMING THE POSITIONAL GUARD WILL RAISE THE EXTERNAL INHIBIT, IF UNEXPECTED MOVEMENT OCCURS. THE PHYSICIST WAS ABLE TO REPRODUCE IGUIDE/HEXAPOD CORRECTIONS WITH THE KEY OFF ON BOTH THE LINACS. THE WORKFLOW (ERROR FLOW) PERFORMED IN ORDER TO DO THIS WAS: OPEN A FRACTION. DO NOT REGISTER. TURN OFF THE IGUIDE KEY. BEAM ON BEFORE DOING ANYTHING ON THE CLOSE FRACTION WINDOW, A 'TREATMENT IN PROGRESS' WINDOW APPEARS. THEN CLICK 'DO NOT MOVE HEXAPOD' ON THE CLOSE FRACTION WINDOW. THE FRACTION DOES NOT CLOSE. REGISTER PATIENT, THEN CONTINUE IN THE NORMAL WORKFLOW, AND HEXAPOD WILL MOVE WITH THE KEY IN THE OFF POSITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227264 IGUIDE SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH P10603-102

    Patients

    Seq Age Sex Outcome Treatment
    1