BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20439052 · Received October 14, 2024

    Report

    Report Number
    3003768277-2024-05803
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 19, 2024
    Report Date
    January 30, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 3003768277-2024-05798. THIS COMPLAINT WILL BE CLOSED AS DUPLICATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT 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
    2230058 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown