BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 7002662 · Received November 6, 2017

    Report

    Report Number
    3004977335-2017-40398
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    April 20, 2016
    Report Date
    November 3, 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 HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE "SMALL FOCUS" OF THE X-RAY TUBE FAILED. IF A FOCUS FAILS ON SYSTEMS OF THIS OLDER VERSION, X-RAY RELEASE IS NO LONGER POSSIBLE. IF A FOCUS FAILS ON NEWER SYSTEM VERSIONS, THERE IS AN AUTOMATIC SWITCH OVER TO THE NEXT LARGER FOCUS. IN THAT CASE, RELEASE OF X-RAY IS POSSIBLE. THE CHANGE OVER TO THE NEWER VERSION TUBES OCCURRED IN 2003. THE X-RAY TUBE WAS EXCHANGED AND THE SYSTEM WAS RETURNED TO CLINICAL USE. NO FURTHER NOTIFICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DFC SYSTEM. DURING A DIAGNOSTIC PROCEDURE, THE USER REPORTED A DARK GRAY FLUORO IMAGE. 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
    782039 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 07412807

    Patients

    Seq Age Sex Outcome Treatment
    1