BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21796021 · Received April 8, 2025

    Report

    Report Number
    3003768277-2025-003265
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 9, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE LEFT CORONARY DIAGNOSTIC PROCEDURE WAS COMPLETED BY RESTARTING THE SYSTEM. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND ANALYSED THE SYSTEM LOG FILE. THE ANALYSIS IDENTIFIED FEEDBACK ERROR IN C-ARC MOTOR. AS A PART OF TROUBLESHOOTING, THE COVERS OF THE L-ARC AND C-ARC MOTORS WERE REMOVED, THE SYSTEM POWER TURNED OFF, AND THE C-ARC MOTOR CABLES TO THE 2SPC MOTOR CONTROLLER WERE RESEATED AFTER FINDING ONE SLIGHTLY LOOSE. AFTER DOUBLE-CHECKING THE CABLE TIGHTNESS AND REASSEMBLING THE COVERS, THE SYSTEM WAS POWERED ON AND TESTED SUCCESSFULLY. HOWEVER, THE ISSUE REOCCURRED, AND THE FSE REPLACED THE AMC(ADVANCED MOTION CONTROLS) DRIVE UNIT IN SEPARATE WORK ORDER. AFTER THAT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS IDENTIFIED THAT THE ISSUE WAS RESOLVED VIA A RESTART, WHICH ALLOWED FOR PROCEDURAL CONTINUATION. IF AN ISSUE OCCURS DURING A PROCEDURE, A WARM/FAST RESTART OR A COLD RESTART MAY BE PERFORMED IN AN ATTEMPT TO RESOLVE THE ISSUE. BY USING THESE MITIGATIONS PROVIDED BY THE DESIGN OF THE DEVICE, THE ISSUE MAY RESOLVE, ALLOWING FOR CONTINUATION AND COMPLETION OF THE PROCEDURE. AN ISSUE WHICH CAN BE RESOLVED BY UTILIZING THE DESIGN MITIGATIONS PROVIDED BY THE DEVICE (WARM/FAST RESTART OR COLD RESTART) IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR AND AS SUCH PHILIPS CONCLUDES THAT THE COMPLAINT IS NOT REPORTABLE THE CODES HAVE BEEN UPDATED BASED ON THE INVESTIGATION'S OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S C-ARM WAS UNABLE TO PERFORM ANGULATION MOVEMENTS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584134 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown