BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22564998 · Received July 22, 2025

    Report

    Report Number
    3003768277-2025-006747
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 8, 2025
    Report Date
    April 15, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099227
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. DURING THE INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO CUSTOMER ALLEGATION RELATED TO WIRELESS FOOTSWITCH (WFS) FUNCTIONALITY. THE SERVICE RECORD ASSOCIATED WITH THIS COMPLAINT WAS CREATED FOR DELIVERY AND INSTALLATION OF A WFS AND BASE STATION. THE INSTALLATION WAS COMPLETED BY A FIELD SERVICE ENGINEER DURING AN ON-SITE VISIT. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. INVESTIGATION IDENTIFIED THAT THERE WAS NO CUSTOMER COMPLAINT OR SYSTEM MALFUNCTION, BUT A SERVICE RECORD WAS GENERATED FOR DELIVERY AND INSTALLATION OF A WFS AND BASE STATION. BASED ON RE-EVALUATION, THIS COMPLAINT IS NOT REPORTABLE. THE FDA ESTABLISHMENT REGISTRATION NUMBER [FEI] HAS BEEN UPDATED AND REPORTED TO THE FDA, CHANGING FROM 3003768277 TO 3042175844, EFFECTIVE DECEMBER 21, 2025. THIS CHANGE REFLECTS AS ADMINISTRATIVE REGISTRATION UPDATE ONLY. THERE HAVE BEEN NO CHANGES TO THE REGISTERED OWNER/OPERATOR, OFFICIAL CORRESPONDENT, LEGAL ENTITY NAME, PHYSICAL ESTABLISHMENT ADDRESS, MANUFACTURING PROCESSES, OR TO THE DESIGN, SPECIFICATIONS, INTENDED USE, OR MANUFACTURING PROCESSES OF ANY LISTED DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE WAS A PROBLEM WITH THE SYSTEM'S WIRELESS FOOTSWITCH, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398127 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M12 00884838099227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown