BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22528230 · Received July 17, 2025

    Report

    Report Number
    3003768277-2025-006408
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838110564
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE CUSTOMER WAS PERFORMING PLANNED NON-EMERGENCY TREATMENT. THE TREATMENT WAS COMPLETED AS PLANNED; THE ISSUE DID NOT AFFECT THE PROCEDURE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SHADOWLESS LIGHT BOOM FIXING BLOCK WAS DISCONNECTED FROM THE TRACK. UPON TROUBLESHOOTING, THE FSE OBSERVED THAT THE SCREWS OF THE FIXING BLOCK OF THE OPERATING LIGHT BOOM WERE LOOSE AND NEEDED TO BE REINFORCED. TO RESOLVE THE ISSUE, THE FSE RESEATED AND REINFORCED THE FIXING BLOCK OF THE OPERATING LIGHT BOOM. AFTER THAT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE A POTENTIAL FOR SERIOUS INJURY, 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. AS PER THE INFORMATION RECEIVED, IF THE PROCEDURE WAS NOT AFFECTED AND THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE AS PLANNED, NORMALLY, ON THE SAME SYSTEM WITH NO DELAY, IT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT RECUR. THEREFORE, BASED ON THIS INVESTIGATION'S RESULTS, PHILIPS CONCLUDES THAT THIS COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE ARM OF THE SHADOWLESS LAMP WAS LOOSE AND ABOUT TO FALL. 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. THE COMPLAINT DEVICE AZURION 5 M20 (722281) IS NOT SOLD IN THE US. HOWEVER, ITS SIMILAR DEVICE 722228 IS MARKETED IN THE US UNDER 510(K): K200917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573038 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M20 00884838110564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown