BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23832370 · Received December 17, 2025

    Report

    Report Number
    3003768277-2025-015786
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 9, 2025
    Report Date
    March 10, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099241
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYZED THE SYSTEM REMOTELY AND FOUND THAT THE PDU HAD NO LED INDICATION. A REVIEW OF SYSTEM LOG FILES SHOWED THE PDU CONTROL MODULE POWER FAILED DUE TO A MALFUNCTIONING PDU FAN TRAY AND DCPS, CONFIRMING THE REPORTED ISSUE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND UPON TROUBLESHOOTING FOUND THE PDU FAN TRAY WAS FAULTY. THE FSE REPLACED PDU FANTRAY AND DCPS TO RESOLVE THE ISSUE AND RESTORED NORMAL FUNCTIONALITY OF THE SYSTEM. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE FAILURE OF THE PDU FANTRAY AND DCPS CAN BE ATTRIBUTED TO THE ISSUES RESOLVED IN PHILIPS CORRECTION 2024-IGT-BST-024. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF THE 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
    2039504 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838099241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown