BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21078899 · Received January 6, 2025

    Report

    Report Number
    3003768277-2025-000089
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 26, 2024
    Report Date
    March 13, 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
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE PROCEDURE WAS COMPLETED IN OTHER WAY AS THE COMMAND OF THE FLUOROSCOPY WAS MALFUNCTIONING IN AN INTERMITTENT WAY. THE DOCTOR PRESSED THE FOOTSWITCH AGAIN AND IT WORKED. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) INSPECTED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM'S WIRED FOOTSWITCH INTERMITTENTLY MALFUNCTIONED. UPON TROUBLESHOOTING, RSE FOUND THE INTERNAL SWITCH OF THE FOOTSWITCH WAS MALFUNCTIONING. TO RESOLVE THE ISSUE, RSE REQUESTED THE SUPPLY OF THE PART. THE CUSTOMER ORDERED AND REPLACED THE WIRED FOOTSWITCH. THE DEFECTIVE WIRED FOOTSWITCH WAS RETURNED TO PHILIPS FOR FAILURE ANALYSIS AND THE CAUSE OF THE WIRED FOOTSWITCH FAILURE WAS FOUND TO BE A DAMAGED CABLE. 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'S WIRED FOOTSWITCH INTERMITTENTLY MALFUNCTIONED, WHICH CAN IMPACT IMAGING. THE DEVICE WAS INSIDE 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
    360865 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