BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 24164546 · Received January 23, 2026

    Report

    Report Number
    3003768277-2026-100360
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 29, 2025
    Report Date
    May 12, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085350
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING UNDERGOING DIAGNOSIS FOR LEFT HEART CATH PROCEDURE. THE PROCEDURE WAS DELAYED 45 MINUTES AND COMPLETED BY MOVING THE PATIENT TO A DIFFERENT ROOM AT THE TIME OF EVENT. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) EXAMINED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM'S MONITOR WAS UNABLE TO DISPLAY THE LIVE IMAGE. UPON TROUBLESHOOTING, THE PHILIPS REMOTE SERVICE ENGINEER (RSE) REBOOTED THE SYSTEM, BUT THE ISSUE PERSISTED. LOGS SHOWED REPEATED STARTUP ERRORS FROM THE SUITE PC (SESSIONMANAGER: PROCESS CRASHED), INDICATING CORRUPT SOFTWARE. THE RSE RECOMMENDED REPLACING THE SUITE PC AND REQUESTED ONSITE VISIT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REVIEWED THE SYSTEM LOG FILE, RAN DIAGNOSTIC HARDWARE TESTS, AND CHECKED BOTH INTERNAL AND EXTERNAL CONNECTIONS OF THE SUITE PC, AND DUE TO MULTIPLE SYSTEM CRASHES AND REBOOTS FSE FOUND ISSUE WITH SUITE PC. TO RESOLVE THE ISSUE, THE FSE REPLACED THE SUITE PC AND RELOADED THE SOFTWARE. THE DEFECTIVE PART WAS SENT FOR ANALYSIS, FOR SUITE PC NO FAILURE WAS FOUND. AFTER REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. 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 MONITOR WAS UNABLE TO DISPLAY THE LIVE IMAGE. 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
    342569 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838085350

    Patients

    Seq Age Sex Outcome Treatment
    1