BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21870996 · Received April 21, 2025

    Report

    Report Number
    3003768277-2025-003591
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 10, 2025
    Report Date
    June 26, 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
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE CARDIOVASCULAR DIAGNOSTIC PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND IDENTIFIED A SOFTWARE FAILURE IN THE SUITE PC. THE ANALYSIS OF SYSTEM LOGFILE SHOWED A GAP BETWEEN THE SYSTEM STARTUP AND SOFTWARE REINSTALLATION THE FSE PROCEEDED TO LOAD SOFTWARE VERSION 2.2.7. AFTER WHICH, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES HAVE BEEN UPDATED BASED ON THE INVESTIGATION'S OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT START UP. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE 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
    1518090 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