BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 6076808 · Received November 3, 2016

    Report

    Report Number
    2240869-2016-03001
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    May 24, 2016
    Report Date
    May 24, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT A FOCUS HEAD FAILS ON AN X-RAY TUBE (REGULARLY X-RAY TUBES ARE EQUIPPED WITH 2 OR 3 FOKI), THIS FAILURE IS DETECTED AND THE OPERATOR CAN SEMI-AUTOMATICALLY SWITCH TO ANOTHER FOCUS IN ORDER TO FINISH THE ONGOING PROCEDURE. DURING THE INVESTIGATION, A FAILURE WAS IDENTIFIED WHERE, UNDER SPECIFIC CIRCUMSTANCES, THE FOCUS SWITCH OVER DOES NOT PERFORM CORRECTLY. SIEMENS HAS INITIATED A FIELD CORRECTIVE ACTION FOR THIS ISSUE WHICH HAS BEEN REPORTED TO THE FDA VIA 806.10 REPORT # 2240869-11/03/16-0032-C. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DFC SYSTEM. DURING A PROCEDURE, NO FLUORO WAS POSSIBLE. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND TRANSFERRED TO AN ALTERNATIVE 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
    729102 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 07412807

    Patients

    Seq Age Sex Outcome Treatment
    1