BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22424344 · Received July 7, 2025

    Report

    Report Number
    3003768277-2025-006124
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 13, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING CARDIOVASCULAR DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS DELAYED AND WAS COMPLETED BY USING ANOTHER SYSTEM. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYSED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM WAS DISPLAYING MESSAGE X-RAY TUBE CURRENTS OUT OF RANGE. THE RSE CHECKED THE LOGS AND IDENTIFIED THAT THE MEASURED TUBE CURRENT WAS LOW. UPON TROUBLESHOOTING, THE RSE RECOMMENDED BIOMED TO CHECK THE CANDLE STICKS AND REPLACE THE HIGH VOLTAGE TRANSFORMER. TO RESOLVE THE ISSUE, THE BIOMED REPLACED THE HIGH VOLTAGE TRANSFORMER. AFTER THIS, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. HEALTH IMPACT AND EVALUATION METHOD CODE WERE CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING A PROCEDURE SYSTEM WAS DISPLAYING MESSAGE X-RAY TUBE CURRENTS OUT OF RANGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SYSTEM. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE 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
    1382466 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown