BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23389661 · Received October 27, 2025

    Report

    Report Number
    3003768277-2025-013138
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    May 27, 2021
    Report Date
    October 27, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085282
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEFINITIVE SOLUTION WAS PROVIDED; PHILIPS SERVICE SUGGESTED DIAGNOSTIC STEPS. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT EXPOSURE ISSUE; SUSPECTED X-RAY TUBE FAULT ON A AZURION 3 M15. THE CLINICAL USE OF THE SYSTEM WAS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797769 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 3 M15 00884838085282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown