BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ICONOS R200

    MDR report key: 6935673 · Received October 10, 2017

    Report

    Report Number
    3004977335-2017-97838
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    PMA / PMN Number
    K992660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. THE PROVIDED LOG FILES DID NOT INDICATE ANY FAILURE DURING THE DEFINED TIMEFRAME. THEREFORE A LONGER TIME PERIOD WAS ANALYZED. IT WAS FOUND THAT (B)(6) 2017 THE MONITORING CONTROL OF UNIT MOVEMENT DETECTED A FAULT DURING TILTING OF ABOUT 1°. THE MOVEMENT WAS BLOCKED BY THE SYSTEM CONTROL. DURING SUCH OCCURRENCES AN ERROR MESSAGE IS DISPLAYED ON THE FLUOROSPOT COMPACT (FLC) AND ON THE GENERATOR CONTROL DESK. AS SOON AS THE ERROR MESSAGE IS CONFIRMED BY PRESSING THE EXPOSURE RELEASE BUTTON, THE SYSTEM RETURNS TO FULL OPERATIONAL MODE. IT WAS FURTHER FOUND THAT (B)(6) 2017 THE SAFETY CIRCUIT WAS OPENED DURING MOVEMENT; HOWEVER IT WAS NOT POSSIBLE TO DETERMINE THE FAULTY MOVEMENT. THE AVAILABLE INFORMATION AND THE INVESTIGATION OF THE LOG FILES POINTED TO A FAULTY JOYSTICK AT THE REMOTE CONTROL DESK. THE REMOTE CONTROL ON THE DESK 1 WAS REPLACED IN (B)(6) 2017,THEREFORE, THE JOYSTICK ON THE REMOTE CONTROL DESK 2 WAS AT FAULT. FURTHER DATA WAS REQUESTED BUT COULD NOT BE PROVIDED. ALSO THE CONTROL DESK 2 WAS REQUESTED FOR INVESTIGATION AS WELL, HOWEVER, IT WAS NOT REPLACED DESPITE SEVERAL REQUESTS. ACCORDING TO INFORMATION RECEIVED FROM THE SITE, THE REMOTE CONTROL DESK 2 WAS DEACTIVATED. NEVERTHELESS, IT IS RECOMMENDED TO REPLACE THE REMOTE CONTROL DESK 2 TO PREVENT ANY FURTHER OCCURRENCES. THE SPARE PART CONSUMPTIONS OF THESE COMPONENTS (JOYSTICK, MATERIAL NUMBER 5292532 AND REMOTE CONTROL DESK, MATERIAL NUMBER 7030708) WERE CHECKED AND SHOWED VALUES THAT ARE BELOW THE DEFINED THRESHOLD. THIS REPORT WAS SUBMITTED JANUARY16, 2018.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). ADDITIONAL INFORMATION ABOUT THE INCIDENT WAS REQUESTED FOR FURTHER INVESTIGATION. THE SYSTEM IS SUPPLIED WITH RED EMERGENCY BUTTON TO STOP ALL SYSTEM MOVEMENTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6).

    Description of Event or Problem · 0

    AN UNINTENDED SYSTEM MOVEMENT WAS REPORTED ON THE AXIOM ICONOS R200 UNIT. THE INCIDENT OCCURRED DURING A SURGICAL PROCEDURE WITH A PATIENT ON THE TABLE. THE TABLE MOVED - 20 DEGREES WITHOUT GIVEN COMMANDS. THE PATIENT WITH INSERTED CATHETER ALMOST FELL OFF THE TABLE. THERE ARE NO INJURIES RELATED TO THIS EVENT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715684 AXIOM ICONOS R200 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA SIEMENS HEALTHCARE GMBH 5902767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other