BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ICONOS R200

    MDR report key: 8504197 · Received April 11, 2019

    Report

    Report Number
    3004977335-2019-70845
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 18, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    PMA / PMN Number
    K992660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED BASED ON THE INFORMATION RECEIVED AND THE PROVIDED ERROR LOGS. THE REPLACED PARTS WERE NOT AVAILABLE FOR INVESTIGATION. THE ANALYSIS OF THE LOG FILES SHOWED NO INDICATION OF MALFUNCTION. THE ISSUE COULD HAVE BEEN CAUSED BY ONE OF THE TWO HARDWARE ISSUES - STUCK TILT BUTTON ON THE TABLE SIDE CONTROL OR A DE-CALIBRATED /DEFECTIVE JOYSTICK IN THE REMOTE CONTROL DESK. THE TWO COMPONENTS (TABLE SIDE CONTROL, MATERIAL NUMBER 7030773 AND CROSS SWITCH WITH POTI, MATERIAL NUMBER 7030765) HAVE BEEN ALREADY REPLACED AT THE CUSTOMER SITE. THE REPLACED PARTS WERE REQUESTED FOR FURTHER ANALYSIS; HOWEVER, THEY HAD BEEN DISPOSED LOCALLY. A DETAILED INVESTIGATION WAS THEREFORE NOT POSSIBLE. HOWEVER, BOTH AFFECTED PARTS SHOW LOW VALUES IN SPARE PART CONSUMPTION. THEREFORE, NO SYSTEMATIC ISSUE IS IDENTIFIED. THE PROBLEM DID NOT RECUR SINCE THE JOYSTICK AND TABLE SIDE CONTROL DESK WERE REPLACED.

    Additional Manufacturer Narrative · 1

    TABLE TILT CONTROLLER AND TABLE SIDE CONTROLLER HAVE BEEN ALREADY EXCHANGED AT THIS SITE. THE UNIT WORKS AS SPECIFIED. INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF UNINTENDED TABLE MOVEMENTS ON THE AXIOM ICONOS R200 UNIT. THE X-RAY TABLE TILTED FROM 90 DEGREE TO 0 DEGREE POSITION WITHOUT GIVEN COMMAND. SIEMENS IS NOT AWARE OF ANY PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299094 AXIOM ICONOS R200 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA SIEMENS HEALTHCARE GMBH 5902775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other