BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DTA

    MDR report key: 6975909 · Received October 25, 2017

    Report

    Report Number
    3004977335-2017-98639
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    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 CUSTOMER REPORTED THAT FLUORO WAS NOT AVAILABLE AND A MICROFOCUS DEFECT HAD OCCURRED. AT THS TIME, THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ACCORDING TO THE LOG FILES, THE MICRO FOCUS OF THE AFFECTED X-RAY TUBE SHOWED ERRORS FOR SOME TIME. AT EACH SYSTEM RESTART, THE GENERATOR DETECTED THE ISSUE, DISABLED THE MICRO FOCUS AND A CORRESPONDING MESSAGE WAS DISPLAYED TO THE USER. IN SUCH CASES, X-RAY IMAGING IS STILL POSSIBLE WITH THE SMALL OR LARGE FOCUS. IF AN ORGAN PROGRAM IS SELECTED USING THE MICRO FOCUS, THE SYSTEM AUTOMATICALLY SWITCHES TO THE SMALL FOCUS. THIS RESULTS IN A MODERATE LIMITATION OF THE IMAGE QUALITY WITH REGARD TO SPATIAL RESOLUTION. THE ROOT CAUSE OF THE MICRO FOCUS ISSUE COULD NOT BE DETERMINED. THE X-RAY TUBE WAS INSTALLED IN 2011. THUS, A POSSIBLE ROOT CAUSE FOR THE MICRO FOCUS ISSUE IS A DEFECT DUE TO WEAR OF THE COMPONENT. THE USER REBOOTED THE SYSTEM RESETTING AND NEWLY INITIALIZING ALL CAN COMPONENTS. AFTER THIS, THE SYSTEM RECOVERED AND THE FULL X-RAY IMAGING FUNCTIONALITY WAS AVAILABLE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755734 AXIOM ARTIS DTA INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7008605

    Patients

    Seq Age Sex Outcome Treatment
    1