BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23364924 · Received October 23, 2025

    Report

    Report Number
    3003768277-2025-012967
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    April 1, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099265
    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 INVESTIGATED THE COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, THE CUSTOMER PLACED A MATERIAL-ONLY ORDER AND DID NOT REPORT ANY INCIDENT OR PATIENT IMPACT. THE CUSTOMER REPORTED TO PHILIPS THAT THE WFS BATTERY WAS NOT CHARGING AND SUSPECTED THE WFS CHARGER TO BE DEFECTIVE. THE CUSTOMER REQUESTED A WFS CHARGER REPLACEMENT FROM PHILIPS. A NEW CHARGER FOR THE WFS WAS ORDERED/SHIPPED TO THE CUSTOMER. FURTHER ANALYSIS OF THE REPLACED WIRELESS FOOTSWITCH CHARGER WAS NOT PERFORMED, AS THE REPLACED COMPONENT IS NOT AVAILABLE. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY UPON RECURRENCE, AND AS SUCH, THE COMPLAINT WAS REPORTED. SINCE THAT TIME, IT WAS IDENTIFIED THAT THE ISSUE OCCURRED WITHOUT PATIENT INVOLVEMENT AND WAS IDENTIFIABLE PRIOR TO PROCEDURE COMMENCEMENT, 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. THE SYSTEM'S INSTRUCTIONS FOR USE WARN THE USER NOT TO UTILIZE THE SYSTEM IF SUSPECTING THAT ANY PART OF THE SYSTEM IS DEFECTIVE AND PROVIDE INFORMATION ON HOW TO VERIFY SYSTEM FUNCTIONALITY. AS THE DEVICE WAS NOT IN USE AT THE TIME THE ISSUE WAS IDENTIFIED, THE USER WOULD IDENTIFY THIS ISSUE BEFORE UTILIZING THE SYSTEM. BASED ON RE-EVALUATION, THIS CASE IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. 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 THE SYSTEM'S WIRELESS FOOTSWITCH WAS UNABLE TO CHARGE, WHICH CAN IMPACT IMAGING. 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
    330025 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838099265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown