BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DBC

    MDR report key: 6480263 · Received April 11, 2017

    Report

    Report Number
    2240869-2017-01905
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 23, 2017
    Manufacturer
    SIEMENS HEALTHINEERS, BUS. 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

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE PROBLEM OCCURRED DUE TO AN ERROR WITHIN THE BSR (IMAGE SYSTEM X-RAY). LOG FILE ASSESSMENT OF PLANE A DOES NOT SHOW A FAILURE. THE IMAGE QUALITY OF PLANE B WAS INVESTIGATED. DURING THE PERIOD OF INTEREST, THE IMAGE QUALITY FOR THAT PERIOD WAS SATISFACTORY. A PROBLEM WITH THE BSR (IMAGE SYSTEM X-RAY) WAS FOUND ON PLANE B. ONLY LIMITED IMAGE QUALITY WAS AVAILABLE FOR APPROXIMATELY 9 MINUTES. AFTER AUTO-RECOVERY, FULL IMAGE QUALITY WAS AGAIN AVAILABLE. THERE WAS NO LIMITATION AND PLANE A WAS FULLY OPERATIONAL. THE SYSTEM PERFORMED A SELF-RECOVERY AND IS OPERATING AS SPECIFIED. FAILURE OF THE BSR IS BEING MONITORED VIA THE CAPA PROCESS. IN CASE OF AN INCREASE, FURTHER ACTIONS ARE TO BE CONSIDERED.

    Additional Manufacturer Narrative · 1

    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. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DBC SYSTEM. DURING A HEART VALVE IMPLANTATION PROCEDURE, THE FLUORO A PLANE IMAGE BECAME TOO BRIGHT. A SYSTEM RESTART WAS ATTEMPTED AT WHICH POINT AN ERROR MESSAGE WAS RECEIVED. 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
    261132 AXIOM ARTIS DBC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS, BUS. AREA ADVANCED THERAPY 07728392

    Patients

    Seq Age Sex Outcome Treatment
    1