BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ICONOS R200

    MDR report key: 13061198 · Received December 22, 2021

    Report

    Report Number
    3004977335-2021-09702
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 22, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    PMA / PMN Number
    K992660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. THE INVESTIGATION OF THE PROVIDED ERROR LOG FILE DID NOT SHOW ANY INDICATIONS FOR SYSTEM MALFUNCTION, WHICH MAY HAVE BEEN CAUSED THE ISSUE. IF A RELEASED BUTTON OR JOYSTICK IS RECOGNIZED DURING INITIALIZATION, THE FUNCTION IS BLOCKED, AND AN ERROR IS STORED IN THE ERROR LOG. THERE WERE NO ENTRIES POINTING TO THIS BEHAVIOR. THE RETURNED JOYSTICKS UNDERWENT A VISUAL AND FUNCTIONAL INSPECTION. PHYSICAL DAMAGE COULD NOT BE SEEN. THE PARTS WERE INSTALLED AND CONNECTED TO A REGULAR CONSOLE ON A FULLY OPERATIONAL ICONOS R200 TEST SYSTEM. FOLLOWING INTENSIVE TESTING, NO MALFUNCTION WAS DETECTED. THERE WAS NO AUTOMATIC MOVEMENT STARTED BY ITSELF AND WHEN THE JOYSTICK LEVER WAS RELEASED, IT WENT ALWAYS BACK TO MIDDLE POSITION AND MOVEMENT WAS STOPPED IMMEDIATELY. THE SPARE PART CONSUMPTION OF THE CONCERNED COMPONENT (7030765) SHOWS VALUES THAT ARE BELOW THE DEFINED THRESHOLD. A POSSIBLE CAUSE FOR THIS ISSUE COULD BE THAT THE LEVER OF THE JOYSTICKS KEPT STICKING OUTSIDE OF THE MIDDLE POSITION WHEN THE USER RELEASED IT. THIS CAN BE CAUSED BY DIRT BETWEEN THE LEVER BASE AND THE CONSOLE SURFACE. SINCE THIS SYSTEM GENERATION HAS NO DEAD MAN GRIP FUNCTION, THE MOVEMENT WILL CONTINUE IN SUCH OCCURRENCES. ANOTHER POSSIBLE CAUSE WOULD BE DIRT IN THE CROSS-SWITCH POTENTIOMETER UNIT ITSELF. DUE TO FRICTION THE MIDDLE POSITION COULD NOT BE REACHED, AND THE MOVEMENT CONTINUED. WHETHER THE DIRT FELL OUT WHEN THE PARTS WERE REPLACED, WHILE TRANSPORTATION OR DURING THE DISINFECTION PROCESS CAN NO LONGER BE CLARIFIED. THE JOYSTICKS WORKED AS SPECIFIED ON THE TEST UNIT AND NO MALFUNCTION COULD BE DETERMINED. IN CASE OF AN UNINTENDED MOVEMENT THE SYSTEM IS EQUIPPED WITH EMERGENCY STOP BUTTONS, WHICH SHUT DOWN ALL SYSTEM DRIVES, AND MOVEMENTS ARE STOPPED IMMEDIATELY. AFTER THE REPLACEMENT OF THE JOYSTICKS NO FURTHER TILTING ISSUES ARE KNOWN.

    Additional Manufacturer Narrative · 0

    ALL SYSTEM MOVEMENTS CAN BE STOPPED BY THE USER AT ANY TIME BY PRESSING THE EMERGENCY STOP BUTTON. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. INTERNAL ID # (B)(4).

    Description of Event or Problem · 0

    UNINTENDED SYSTEM MOVEMENT WAS REPORTED FOR THE AXIOM ICONOS R200 DEVICE. THE USER STATED THAT THE SYSTEM STARTED TILTING WITHOUT GIVEN COMMAND FROM 90 DEGREES TO 0 DEGREES DURING A PATIENT EXAM. IN ADDITION TO THE TILT MOVEMENT THE COLUMN STARTED TO MOVE TOWARDS THE FOOT END. A PATIENT IN A WHEELCHAIR WAS PRESENT IN THE EXAM ROOM DURING THE EVENT, HOWEVER, THE PATIENT WAS NOT POSITIONED ON THE TABLE. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966054 AXIOM ICONOS R200 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA SIEMENS HEALTHCARE GMBH 5902775

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other