BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23023757 · Received September 11, 2025

    Report

    Report Number
    3003768277-2025-009760
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 28, 2025
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT FROM AN ALREADY REPORTED COMPLAINT. THE INVESTIGATION WILL BE ADDRESSED IN MFR REPORT NUMBER 3003768277-2025-011277. THIS COMPLAINT WILL BE CLOSED AS DUPLICATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM HAD A POWER FAILURE. 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
    2708831 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