BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 23509283 · Received November 10, 2025

    Report

    Report Number
    3003768277-2025-014391
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 14, 2025
    Report Date
    March 3, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838116801
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH DELAY OF LESS THAN 20 MINUTES. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) CHECKED THE SYSTEM REMOTELY AND CONFIRMED THAT THE IMAGE AT 15:12 IS NO LONGER DISPLAYED. UPON TROUBLESHOOTING, THE RSE IDENTIFIED THE MONITOR AND TOUCH PANEL SCREENS WENT BLANK. THE RSE REVIEWED SYSTEM LOG FILES AND FOUND THAT THE BODYGUARD REPEATEDLY ISSUED THE "APCACCEPTBUTTON" COMMAND, CAUSING THE SOFTWARE TO RESTART AND THE ICONTROL INTERFACE TO LOSE CONNECTION WITH THE INTERNAL COMPONENT. ADDITIONAL REVIEW OF THE SYSTEM LOGS REVEALED XRAY SERVICE CRASH WITH COLLISION AND APC USAGE. TO RESOLVE THE ISSUE, THE SOFTWARE WAS RESTARTED. AFTER WHICH, 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 PRODUCT MALFUNCTION WITH 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 IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PER THE INFORMATION RECEIVED THE PROCEDURE WAS NOT AFFECTED, AND THE CUSTOMER WAS ABLE TO COMPLETE AS PLANNED WITH THE SAME SYSTEM WITH MINIMUM DELAY, IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT RECUR. THEREFORE, BASED ON THIS INVESTIGATION 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 AUTOMATIC POSITION CONTROL ACCEPT BUTTON WAS PRESSED MULTIPLE TIMES, PREVENTING IMAGING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. 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
    312884 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838116801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown