BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 4669091 · Received April 1, 2015

    Report

    Report Number
    2240869-2015-01423
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 11, 2015
    Manufacturer
    SIEMENS AG
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Removal / Correction Number
    2240869-08/19/14-0025-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FACTORY EXPERTS REQUESTED THE ERROR LOG FILES FOR FURTHER INVESTIGATION. IT IS ASSUMED THAT THE UNINTENDED TABLE MOVEMENT WAS CAUSED BY A KNOWN ISSUE WITH THE TABLE SIDE CONTROL. THIS ISSUE WAS ADDRESSED IN THE CUSTOMER SAFETY ADVISORY LETTER XP045/14/S, REPORTED UNDER CORRECTIONS AND REMOVALS REPORT # 2240869-08/19/14-0025-C (Z-2649-2014). A LOCAL SERVICE ENGINEER WAS INFORMED THAT A FIX FOR THE ISSUE WAS DISTRIBUTED VIA AN UPDATE INSTRUCTION XP072/14/S (REPORTED AS A PART OF THE ORIGINAL C&R SUBMISSION # 2240869-08/19/14-0025-C). THE ENGINEER WAS ADVISED TO PERFORM THE UPDATE TO ELIMINATE THE ISSUE. THE TABLE SIDE CONTROL WAS ALSO REQUESTED FOR FURTHER INVESTIGATION. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED 03/31/2015. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DETAILED INVESTIGATION OF THE RETURNED TABLE SIDE CONTROL PANEL SHOWED THAT THE DESCRIBED EVENT WAS CAUSED BY INFILTRATION OF FLUIDS. TO AVOID SUCH ISSUES A REDESIGN OF THE TABLE SIDE CONTROL PANEL HAS BEEN ALREADY IMPLEMENTED VIA AN UPDATE INSTRUCTION (B)(4) (REPORTED UNDER CORRECTIONS & REMOVALS REPORT # 2240869-08/19/14-0025-C/Z-2649-2014).

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, AN ENDOSCOPE CONSIDERABLY CAME OUT OF THE ORIGINAL POSITION DUE TO AN UNINTENDED TABLE MOVEMENT OF THE AXIOM LUMINOS TF SYSTEM. THERE ARE NO INJURIES ATTRIBUTED TO THE EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214360 AXIOM LUMINOS DRF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY OWB SIEMENS AG 10094200 NS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other