BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22952741 · Received September 3, 2025

    Report

    Report Number
    3003768277-2025-008893
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    March 30, 2022
    Report Date
    September 3, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K181830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS SERVICE REPLACED THE NIU BOARD AND RETURNED THE DEVICE TO USE. 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 AN NIU BOARD FAILURE CAUSED A GEOMETRY POSITIONING ISSUE ON AN AZURION 7 M20. 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
    1336081 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown