BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22783664 · Received August 12, 2025

    Report

    Report Number
    3003768277-2025-007237
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 16, 2025
    Report Date
    November 3, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085367
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. THE USER INDICATED THAT A DELAY WITH THE WIRELESS FOOTSWITCH (WFS) WAS EXPERIENCED DURING A TEST EXPOSURE. TO RESOLVE THE PROBLEM, FSE PERFORMED A WFS FUNCTIONAL TEST, AND THE SYSTEM WAS FOUND TO BE WORKING PROPERLY. NO FAILURE WAS IDENTIFIED. THE SYSTEM WAS CONFIRMED TO BE OPERATING NORMALLY. 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, 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 IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PER THE INSTRUCTIONS FOR USE, THE USER OF THE PRODUCT MUST INSTITUTE A USER ROUTINE CHECKS PROGRAM. THE USER OF THE PRODUCT SHALL MAKE SURE THAT ALL CHECKS AND ACTIONS HAVE BEEN SATISFACTORILY COMPLETED BEFORE USING THE PRODUCT FOR ITS INTENDED PURPOSE. IT IS INSTRUCTED TO NOT USE THE PRODUCT FOR ANY APPLICATION UNTIL THE USER IS SURE THAT THE USER ROUTINE CHECKS HAVE BEEN SATISFACTORILY COMPLETED, THEREFORE, AS THE DEVICE WAS OUTSIDE OF USE AT THE TIME THE ISSUE WAS IDENTIFIED, THE USER WOULD IDENTIFY THIS ISSUE PRIOR TO USE AND THE ISSUE HAPPENED DUE TO IMPROPER MAINTENANCE. BASED ON RE-EVALUATION, THIS CASE IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FOOTSWITCH GAVE AN ERROR, WHICH CAN IMPACT IMAGING. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413492 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838085367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown