BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24113493 · Received January 20, 2026

    Report

    Report Number
    3003768277-2026-100274
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 18, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT BOOTING UP. THE REVIEW OF SYSTEM LOG FILES SHOWED MALFUNCTION WITH THE UPS. UPON TROUBLESHOOTING, THE FSE FOUND 1 PHASE UPS NOT RECEIVING SUFFICIENT POWER, 84VAC. AND FOUND F4 FUSE BLOWN IN NYU. TO RESOLVE THE ISSUE, THE FSE REPLACED THE FUSE AND BYPASSED THE UPS. SYSTEM FUNCTIONAL TESTS WERE PERFORMED, AND 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 OUTSIDE OF 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
    178124 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown