BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23029936 · Received September 11, 2025

    Report

    Report Number
    3003768277-2025-009901
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 19, 2025
    Report Date
    February 15, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099234
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) IDENTIFIED THROUGH REMOTE MONITORING THAT THE SYSTEM HAD GENERATED AN ALERT DUE TO LOW DISK SPACE ON THE SUITE PC. THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED ONSITE AND REVIEWED THE INTERNAL HARD DRIVE STORAGE CONTAINING PATIENT DATA. THE FSE REMOVED PREVIOUSLY BACKED UP FILES TO RECOVER AVAILABLE DISK SPACE AND THEN REBOOTED THE SYSTEM, RESTORING NORMAL OPERATION. AFTER DELETING THE BACKUP PATIENT DATA, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING THE IMAGE DISK SPACE WAS LOW, WHICH CAN IMPACT IMAGING. 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
    2232982 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5M20 00884838099234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown