BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21837885 · Received April 15, 2025

    Report

    Report Number
    3003768277-2025-003452
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 19, 2025
    Report Date
    June 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, PLANNED NEUROVASCULAR TREATMENT WAS PERFORMED BY THE CUSTOMER WHEN THE ISSUE OCCURRED AND THE PROCEDURE WAS ABORTED AND COMPLETED THE FOLLOWING DAY. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON SITE AND CONFIRMED DURING PROCEDURE THE CONNECTION TO THE MWM WAS LOST, RESULTING IN THE IW IMAGES NO LONGER BEING DISPLAYED. FOLLOWING A RESTART, THE DEVICE FAILED TO POWER ON. UPON TROUBLESHOOTING, FSE FOUND FAILURE IN THE IW AND MWM CONNECTION. TO RESOLVE THIS ISSUE, FSE REPLACED SUITE PC. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION 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 COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121879 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown