BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23591796 · Received November 19, 2025

    Report

    Report Number
    3003768277-2025-014837
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 7, 2025
    Report Date
    January 23, 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. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. CUSTOMER REPORTED TO PHILIPS THAT THE SYSTEM WAS NOT BOOTING UP. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND OBSERVED THAT SYSTEM HAD A LONG STARTUP TIME AND STUCK AT START UP. UPON TROUBLESHOOTING, THE FSE FOUND THE CAUSE OF THE ISSUE WAS DUE TO ERRORS WITHIN THE PDU DSM (POWER DISTRIBUTION UNIT DUAL SWITCH MODULE) AND PDU CONTROL MODULE AT START UP. THE SUPPLIER'S PART ANALYSIS COULD NOT FIND THE CAUSE OF THE PDU DSM AND PDU CONTROL MODULE FAILURE. HOWEVER, REPLACING PDU DSM AND PDU CONTROL MODULE BY THE FSE, HAD RESTORED THE SYSTEM FUNCTIONALITY. THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING CONDITION. 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 UP. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858759 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