BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 10284143 · Received July 16, 2020

    Report

    Report Number
    2020563-2020-00004
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 19, 2020
    Report Date
    October 5, 2020
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE TABLE SIDE CONSOLE WAS REPLACED AT THE SITE, IT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE RESULT OF THE INVESTIGATION IS AS FOLLOWS. THE COVER OF THE SWITCH WAS NOT RETURNED BECAUSE IT WAS DISPOSED AT THE SITE. THE COMPLETION OF THE INVESTIGATION WAS DELAYED BECAUSE THE SWITCH COVER, WHICH WAS IMPORTANT FOR THE INVESTIGATION, WAS NOT RETURNED AND IT TOOK TIME TO OBTAIN THE INFORMATION NECESSARY FOR THE INVESTIGATION REGARDING THE RETURNED PARTS.RETURNED PARTS WITHOUT THE COVER WERE INVESTIGATED, AND MANUFACTURER FOUND NO ABNORMALITIES. MANUFACTURER CONDUCTED REPRODUCTION TEST WITH USING ANOTHER COVER OF A SWITCH. MANUFACTURER ASSUMED IN THE TEST THAT THE BROKEN COVER WAS SQUEEZED AND PUSHED THE UNDERLYING SWITCH. MANUFACTURER CONSIDERED THAT THE TILTED SWITCH MADE C-ARM MOVE WITHOUT USER OPERATION BEFORE THE COVER CAME OFF. IT WAS NOTED THAT THIS IS AN EXTREMELY RARE CASE. AS A RESULT OF THE LOG INVESTIGATION, MANUFACTURER DID NOT FIND ANY ERROR OCCURRENCE FOR THE DEVICE AT THE EVENT TIME. AFTER THE INCIDENT, CANON CUSTOMER ENGINEER CHECKED ALL SAFETY FUNCTIONS (TOUCH SENSORS AND EMERGENCY STOP SWITCHES) AND CONFIRMED THAT FUNCTIONS WERE WORKING PROPERLY. THE USER COULD STOP C-ARM MOVEMENT USING EMERGENCY STOP SWITCHES. FURTHERMORE, C-ARM WAS SLOWED DOWN AROUND THE PATIENT BY INTERFERENCE PREVENTION FUNCTION. THESE FUNCTIONS ENSURE SAFETY IN A SCENARIO SUCH AS THIS CASE. THIS CASE IS THE FIRST REPORT OF ITS KIND TO THE MANUFACTURER. CUSTOMER ENGINEER HAS REPLACED THE TABLE SIDE CONSOLE, AND THE REPAIR HAS BEEN COMPLETED. THEREFORE, IT IS JUDGED THAT NO FURTHER CORRECTIVE ACTION IS NEEDED IN THIS CASE. IN REGARDS TO PREVENTATIVE ACTION, THE EMERGENCY STOP BUTTOM TO STOP MOVEMENT OF THE C-ARM SUPPORT UNIT, AS OUTLINED IN THE SYSTEM OPERATION MANUAL, WILL BE EXPLAINED AGAIN TO THE CUSTOMER.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THAT DURING A USER CONTROLLED C-ARM MOVEMENT WITH A TABLESIDE CONSOLE, THE HYPER HANDLE BUTTON TO CONTROL DIRECTION AND SPEED WAS BROKEN. CUSTOMER ALLEGED THAT THE C-ARM CONTINUED TO MOVE AND HIT THE PATIENT, AGAINST THE USER'S INTENTION. ACCORDING TO THE CUSTOMER, A TOUCH SENSOR EQUIPPED TO THE C-ARM WAS ACTIVATED, AND THE C-ARM WAS STOPPED. CUSTOMER REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE ACCIDENT HAPPENED BETWEEN 8:00 AND 8:30 AM ON FRIDAY (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    TO JUDGE THE NEED OF CORRECTIVE AND PREVENTATIVE ACTIONS, IF ANY, THE MANUFACTURER MUST INVESTIGATE THE BROKEN CONSOLE AND HYPER HANDLE IN DETAIL. AFTER RECEIVING THOSE PARTS, MANUFACTURER WILL UPDATE THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT DURING A USER CONTROLLED C-ARM MOVEMENT WITH A TABLESIDE CONSOLE, THE HYPER HANDLE BUTTON TO CONTROL DIRECTION AND SPEED WAS BROKEN. CUSTOMER ALLEGED THAT THE C-ARM CONTINUED TO MOVE AND HIT THE PATIENT, AGAINST THE USER'S INTENTION. ACCORDING TO THE CUSTOMER, A TOUCH SENSOR EQUIPPED TO THE C-ARM WAS ACTIVATED, AND THE C-ARM WAS STOPPED. CUSTOMER REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE ACCIDENT HAPPENED BETWEEN 8:00 AND 8:30 AM ON FRIDAY (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751413 CANON INFINIX-I JAA CANON MEDICAL SYSTEMS CORPORATION INFX-8000F/AH

    Patients

    Seq Age Sex Outcome Treatment
    1