BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 8170451 · Received December 17, 2018

    Report

    Report Number
    2020563-2018-00003
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 10, 2018
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LOG DATA WAS REVIEWED AND THE RESULTS OF THE INVESTIGATION IS TWO-FOLD: (A) PROBLEM WITH THE CABLE CONNECTION AND CONNECTION DIAGRAMS FOR THE INTERLOCK FUNCTION, WHICH SHOULD HAVE STOPPED THE TABLE FROM TILTING AND (B) TABLE TILTING WAS CAUSED BY A LIQUID SPILLING ONTO THE TILT CONSOLE. IT WAS DETERMINED FROM THE INVESTIGATION BY THE MANUFACTURER THAT LIQUID SPILLING ONTO THE TILT CONSOLE TRIGGERED A SHORT CIRCUIT WHICH CAUSED THE TABLE TO TILT UNEXPECTEDLY. THIS IS BEING CONSIDERED USER ERROR BECAUSE PER THE CAUTION SECTION OF THE OPERATION MANUAL THE TABLESIDE CONSOLE AND X-RAY DETECTORS OF THE SUPPORT UNITS ARE TO BE COVERED WITH STERILE CAPS TO PREVENT CONTACT WITH LIQUIDS. THIS WAS NOT THE CASE. ADDITIONALLY, THE TABLE TILT MOVEMENT SHOULD HAVE BEEN STOPPED BY THE INTERLOCK FUNCTION. HOWEVER THE INTERLOCK FUNCTION WAS NOT FUNCTIONING. IT WAS FOUND THAT THERE WAS A PROBLEM WITH THE CABLE CONNECTION BECAUSE THE CONNECTION DIAGRAM WAS INCORRECT. THE CABLE CONNECTION AND THE CONNECTION DIAGRAM WILL BE MODIFIED TO CORRECT THE PROBLEM ON ALL APPLICABLE SYSTEMS. THE CAT-870B TABLE HAS BEEN REPLACED AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    TABLE TILTED UNCOMMANDED INTO C- ARM OF SYSTEM CAUSING DAMAGE TO THE INTERNAL WORKINGS OF THE TABLE. THE PATIENT WAS ON THE TABLE WHEN THIS OCCURRED, BUT WAS UNHURT. IT WAS REPORTED BY THE CUSTOMER THAT THE TABLE BEGAN TILTING WITH THE PATIENT ON THE TABLE WITHOUT OPERATION INTERVENTION. THEY WERE ABLE TO GET THE PATIENT OFF THE TABLE WITHOUT INJURY. HOWEVER, THE TABLE CONTINUED TO TILT INTO THE C-ARM CAUSING IRREPARABLE DAMAGE TO THE TABLE. A REPLACEMENT TABLE HAS BEEN ORDERED. PLEASE NOTE THAT PRIOR TO THE TABLE TILTING, A NURSE PIERCED A HEPARIN BAG THAT WAS TO BE HUNG ON THE IV POLE ON THE LEFT SIDE OF THE TABLE. THE BAG RUPTURED SATURATING THE TILT CONSOLE AND THE FOOT OF THE TABLE TOP WITH THE HEPARIN. THE AREAS WERE CLEANED, BUT SOON AFTER THE EVENT (TABLE TILT) OCCURRED. THE TABLE, TABLE CONTROL POWERBOARD AND CONNECTING CABLE ARE BEING RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    TABLE TILTED UNCOMMANDED INTO C-ARM OF SYSTEM CAUSING DAMAGE TO THE INTERNAL WORKINGS OF THE TABLE. PATIENT WAS ON THE TABLE, BUT WAS UNHURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010556 CANON CATHETERIZATION TABLE IXR CANON MEDICAL SYSTEMS CORPORATION CAT-870B

    Patients

    Seq Age Sex Outcome Treatment
    1