BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 13861798 · Received March 23, 2022

    Report

    Report Number
    2020563-2022-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 8, 2022
    Manufacturer
    CANON MEDICAL SYSTEM CORPORATION
    Product Code
    OWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM IS A VASCULAR (INFX-8000C/BH) SYSTEM COMBINED WITH A CT (TSX-305A/6) SYSTEM.. RESULTS OF THE INVESTIGATION CONDUCTED BY THE MANUFACTURER ARE AS FOLLOWS: WHEN THE INTERNAL COMMUNICATION ERROR ON INFX-8000C/BH OCCURRED, THE SYSTEM WAS IN AN ERROR STATE AND THE CT OPERATION WAS RESTRICTED BY AN INTERLOCK MECHNISM. THE OPERATOR TRIED TO RELEASE THE ERROR BY RESETTING THE SYSTEM, BUT WAS NOT SUCCESSFUL. TWO RESET OPERATIONS ONE ON THE VL SIDE AND THE OTHER ON THE CT SIDE ARE REQUIRED. APPLICABLE VASCULAR (INFX-8000C/BH) SYSTEM COMBINED WITH A CT (TSX-305A/6) SYSTEM, WILL REQUIRE AN UPDATE TO THE FIRMWARE. CT SYSTEM. SERIAL NO.(B)(6)-MODEL NO.: TSX-305A/G; PRODUCT CODE: JAK; COMMON DEVICE NAME: SYSTEM, X-RAY TOMOGRAPHY COMPUTED.

    Additional Manufacturer Narrative · 0

    RESULTS OF THE INVESTIGATION. AS A RESULT OF THE INVESTIGATION, THE FOLLOWING HAS BEEN FOUND: BASED ON THE LOG RECORDS, AT THE TIME OF THE EVENT, THE CT OPERATION WAS RESTRICTED BY THE INTERLOCK DUE TO THE ERROR ON THE INFX-8000C SYSTEM. THE OPERATOR ATTEMPTED TO RECOVER FROM THE ERROR BY PRESSING THE OVERRIDE/ ANATOMIC ANGLE RESET BUTTON ONCE TO CLEAR THE ERROR ON THE INFX-8000C SYSTEM AND THE INTERLOCK ON THE CT SYSTEM. ALTHOUGH THE ERROR ON THE INFX-8000C SYSTEM WAS CLEARED, THE INTERLOCK ON THE CT SYSTEM WAS NOT RESET. IF THE OPERATOR HAD PRESSED THE RESET BUTTON TWICE AS A WORKAROUND, THE INTERLOCK WOULD HAVE RESET ON THE CT SYSTEM. THE CAUSE OF THIS ISSUE IS THE INSUFFICIENT HANDLING OF THE RESET BY THE SOFTWARE ON THE C ARM SUPPORT DEVICE (CAS-930A) IN THE INFX-8000C SYSTEM. WHEN THE CT OPERATION IS RESTRICTED BY THE INTERLOCK DUE TO THE ERROR ON THE INFX-8000C SYSTEM, THE INTERLOCK ON THE CT SYSTEM SHOULD BE RESOLVED BY ONE RESET OPERATION FROM THE INFX-8000C SYSTEM. HOWEVER, THE HANDLING OF THE INTERLOCK BY THE SOFTWARE ON THE INFX-8000C SYSTEM IS INSUFFICIENT FOR THE CASE WHERE THE INFX-8000C SYSTEM IS IN COMBINATION WITH THE CT SYSTEM. FOR THE CAS-930A STANDALONE SYSTEM, THIS ERROR WILL BE RESOLVED WITH ONCE RESET OPERATION.

    Description of Event or Problem · 0

    PATIENT POSITIONED ON TABLE FOR SECOND HALF OF COMBINATION CASE TO OBTAIN CT SCAN OF THORACOLUMBAR SPINE. GANTRY REACHED INNER LIMIT AND ERROR MESSAGE PREVENTED SCAN. NO PATIENT INJURY OCCURRED, BUT PATIENT CONDITION WAS AFFECTED WITH MULTIPLE TRANSFERS OF PATIENT INTO ADJACENT CT ROOM.

    Description of Event or Problem · 0

    PATIENT POSITIONED ON TABLE FOR SECOND HALF OF COMBINATION CASE TO OBTAIN CT SCAN OF THORACOLUMBAR SPINE. GANTRY REACHED INNER LIMIT AND ERROR MESSAGE PREVENTED SCAN. NO PATIENT INJURY OCCURRED, BUT PATIENT CONDITION WAS AFFECTED WITH MULTIPLE TRANSFERS OF PATIENT INTO ADJACENT CT ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018286 CANON SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED INTERVENTIONAL FLUOROSCOPIC X-RAY OWB CANON MEDICAL SYSTEM CORPORATION INFX-8000C/BH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other