BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 7315950 · Received March 6, 2018

    Report

    Report Number
    3004977335-2018-17924
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 15, 2018
    Report Date
    February 15, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. NO ROOT CAUSE FOR THE REPORTED TABLE BEHAVIOR COULD BE DETERMINED. A DETAILED ANALYSIS OF THE PROVIDED LOG FILES SHOWED THAT THE PROBLEM OCCURRED AFTER SYSTEM STARTUP AT 17:19:57. DURING STARTUP OF THE STAND CONTROL UNIT (SCU) AN ACTIVE DEAD MAN GRIP (DMG) WAS DETECTED BY THE SYSTEM. THE SYSTEM DISPLAYED THE MESSAGE "DEACTIVATE DMG OR CALL SERVICE" TO THE USER. IT IS ASSUMED THAT EITHER A DEFLECTED JOYSTICK OR A HANGING BUTTON ON THE OIB INITIATED THE REPORTED MOVEMENT. THE POTENTIALLY DEFECTIVE OIB COULD NOT BE INVESTIGATED BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. THE AFFECTED SYSTEM IS EQUIPPED WITH A SIEMENS OPERATING ROOM (OR) TABLE. THE TABLE MOVEMENTS CAN BE CONTROLLED BY THREE USER INTERFACES: TWO TABLE CONTROL MODULES (TCMS) LOCATED AT THE OR TABLE, A HAND CONTROL AND A FOOTSWITCH. THE HAND CONTROL AS WELL AS THE FOOTSWITCH IS CONNECTED VIA THE OPERATING TABLE INTERFACE BOARD (OIB) TO THE SYSTEM. OR TABLE MOVEMENTS ARE AT LOW SPEED ONLY (<250 MM/SEC). THE SYSTEM IS EQUIPPED WITH SEVERAL SAFETY MECHANISMS WHICH WILL HELP TO PREVENT COLLISIONS DURING UNIT MOVEMENTS. COLLISION COMPUTER: A COMPUTER CONSTANTLY CALCULATES ALL POSSIBLE COLLISIONS BETWEEN THE STANDS/C-ARM(S) AND THE PATIENT TABLE. SPEED REDUCTION FOR ALL MOVEMENTS PROVIDING AMPLE TIME FOR THE USER TO PRESS ONE OF THE NEAREST EMERGENCY STOP BUTTONS: MOVEMENTS ARE STOPPED IMMEDIATELY WHEN AN EMERGENCY STOP BUTTON IS BEING PRESSED BY THE USER AS DESCRIBED IN THE OPERATOR MANUAL VOL. 1, CHAPTER - SAFETY NOTES AND RADIATION PROTECTION. THE SPEED IS AUTOMATICALLY REDUCED FOR MOVEMENTS IN THE COLLISION AREA OR IN PARTICULAR SYSTEM POSITIONS AND MOVEMENT IS STOPPED, IF NECESSARY BY COLLISION SENSORS: IN CASE OF A COLLISION, SENSORS, E.G. ON THE FLAT PANEL DETECTOR COVERS, WILL AUTOMATICALLY STOP THE MOVEMENT. THE SERVICE ENGINEER REPLACED THE CONTROL MODULES AND THE OPERATING TABLE INTERFACE BOARD. NO FURTHER ACTIONS ARE TO BE TAKEN AS THERE IS NO NEGATIVE AWARENESS IN REGARDS TO THE QUALITY AND PERFORMANCE OF THE AFFECTED COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DFC SYSTEM. THE USER REPORTED THAT THE TABLE STARTED DRIFTING TO THE FOOT END BY ITSELF AND STARTED MOVING UP UNTIL IT REACHED THE MAXIMUM HEIGHT. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR OPERATOR INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162568 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7727717

    Patients

    Seq Age Sex Outcome Treatment
    1