BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21372980 · Received February 13, 2025

    Report

    Report Number
    3003768277-2025-001426
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 19, 2025
    Report Date
    March 31, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085350
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP, STALLING AT THE STARTUP SCREEN. UPON TROUBLESHOOTING, THE PHILIPS REMOTE SERVICE ENGINEER (RSE) CHECKED THE SYSTEM LOG REMOTELY AND FOUND INTERNAL SOFTWARE ERROR (NOT A HARDWARE ERROR) AND ERROR APPEARED INDICATING THAT COM SERVER WAS NOT AVAILABLE. TO RESOLVE THE ISSUE, RSE PERFORMED A COLD RESTART. AFTER RESTART THE DEVICE RETURNED TO 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 UNABLE TO STORE IMAGE 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 UNABLE TO STORE IMAGE 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 WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP, STALLING AT THE STARTUP SCREEN. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638695 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838085350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown