BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DTA

    MDR report key: 7186144 · Received January 12, 2018

    Report

    Report Number
    3004977335-2018-08446
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 7, 2017
    Report Date
    January 8, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE ISSUE REGARDING THE FSW OR THE USER LOCATION INTERFACE (ULI) WHICH PASSES THE SIGNALS TO THE SYSTEM. THE INVESTIGATION OF THE PROVIDED LOG FILES SHOWED THAT 9 OUT OF 38 ATTEMPTS TO RELEASE RADIATION VIA THE ACQUISITION PEDAL WERE SUCCESSFUL. MOST OF THE X-RAY REQUESTS WERE ABORTED BECAUSE THE COMBINED SIGNAL OF ALL CHANNELS OF THE FSW WAS MISSING. THIS INDICATES A HARDWARE ISSUE REGARDING THE FSW OR THE USER LOCATION INTERFACE (ULI) WHICH PASSES THE SIGNALS TO THE SYSTEM. THE SIEMENS SERVICE ENGINEER (CSE) REPLACED THE FSW AND THE ULI BOARD ON THE TABLE SIDE. AFTER THE REPLACEMENT OF PARTS THE SYSTEM WORKED AS EXPECTED. THE MANUFACTURER IS NOT PLANNING ADDITIONAL CORRECTIVE ACTIONS AT THIS TIME. RESUBMISSION OF SUPPLEMENT REPORT AS PER FDA ON 4/4/2019.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DTA SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT IMAGE ACQUISITION WAS NOT POSSIBLE. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND TRANSFERRED TO AN ALTERNATE SYSTEM WHERE THE PROCEDURE WAS COMPLETED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29108 AXIOM ARTIS DTA INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7008605

    Patients

    Seq Age Sex Outcome Treatment
    1