BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 8414464 · Received March 12, 2019

    Report

    Report Number
    2020563-2019-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    October 22, 2018
    Report Date
    March 12, 2019
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TOUCH SENSOR DETECTS A CONTACT WHEN A LOAD EXCEEDS A CERTAIN THRESHOLD. IT IS CONSIDERED THAT THE TOUCH SENSOR DID NOT DETECT A CONTACT BECAUSE THE CONTACT FORCE WAS LOWER THAN ITS THRESHOLD. THIS IS THE DEVICE SPECIFICATION. THE FOLLOWING MEASURES ARE IMPLEMENTED AND PERFORMED SO THAT TOUCH SENSORS WORKS AS INTENDED: THE SYSTEM HAS A FUNCTION THAT DETECTS FAILURE FOR TOUCH SENSORS. IT HAS A FAIL-SAFE DESIGN AND IS CONFIGURED TO DETECT FAULTS. SO, WHEN THE FAIL-SAFE FUNCTION OPERATES, A SYSTEM ERROR WILL GENERATE. DETECTOR MOVEMENTS ARE SLOWED DOWN AROUND A PATIENT BY AN INTERFERENCE PREVENTION FUNCTION. TOUCH SENSORS ARE INSPECTED TO WORK CORRECTLY WHEN THEY ARE SHIPPED, AND ONCE AGAIN ONCE THEY ARE INSTALLED AT THE SITE. CUSTOMERS NEED TO PERFORM PRE-OPERATIONAL CHECKS WHEN THEY START A STUDY EVERYDAY. THIS IS NOTED IN THE OPERATION MANUAL. THE FOLLOWING CONTENTS DESCRIBED IN THE OPERATION MANUAL WILL BE EXPLAINED ONCE AGAIN TO THE CUSTOMER: PRE-OPERATIONAL CHECK TO CONFIRM THAT TOUCH SENSORS WORK SAFELY AND AS INTENDED. TO BE MINDUL THAT THE TOUCH SENSOR MAY PUSH AGAINST A PATIENT. WE JUDGE THAT NO FURTHER ACTION BEYOND WHAT IS SPECIFIED IN THIS SUMMARY IS NEEDED. [MEDWATCH REPORT MW5081940].

    Description of Event or Problem · 1

    FROM THE ORIGINAL MEDWATCH REPORT SUBMITTED BY THE FACILITY: "FEMALE PATIENT HAD BEEN FOUND TO HAVE HAD AN ENLARGING LESION IN THE RIGHT POSTEROLATERAL PORTION OF THE RIGHT LOBE OF THE LIVER. THIS LESION UNDERWENT BIOPSY. ON STANDING THE PATIENT UP, SHE BECAME ORTHOSTATIC AND TACHYCARDIC AND THERE WAS CONCERN ABOUT POST-BIOPSY BLEEDING. THE PATIENT WENT FOR A STAT CTA WHERE THERE WAS SEEN TO BE SOME EXTRAVASATION. SHE THEN WENT FOR A STAT ARTERIAL EMBOLIZATION. DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, THE FPD SENSOR IN THE INTERVENTIONAL SUITE LOWERED DOWN AND TOUCHED THE PATIENT'S ABDOMEN. NORMALLY, UPON TOUCHING THE PATIENT, THE FPD SENSOR RAISES UP AND PREVENTS ITSELF FROM TOUCHING THE PATIENT. THIS DAY, THE SENSOR DID NOT WORK AND THE SENSOR STAYED AGAINST THE PATIENT, CAUSING HER SOME PAIN. THE FPD SENSOR WAS IMMEDIATELY LIFTED OFF OF THE PATIENT BY THE RADIOLOGY TECHNICIAN STANDING NEXT TO HER. THE THIRD PARTY MAINTENANCE COMPANY WAS CALLED, AND THE FPD SENSOR WAS REPLACED". PLEASE NOTE THAT THE CUSTOMER MISTAKENLY NOTED THE FPD SENSOR AS THE IMAGE INTENSIFIER. THIS HAS BEEN CORRECTED IN THE ABOVE REPORT FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205470 CANON INFINIX VC-I FD VASCULAR SYSTEM JAA CANON MEDICAL SYSTEMS CORPORATION INFX-8000C/UD

    Patients

    Seq Age Sex Outcome Treatment
    1