BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22884026 · Received August 25, 2025

    Report

    Report Number
    3003768277-2025-007991
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 12, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE SYSTEM'S C-ARM MOVEMENT WAS ONLY PARTIALLY AVAILABLE. ONSITE SERVICE WAS RECOMMENDED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED ISSUE. TROUBLESHOOTING AND ASSESSMENT OF THE SYSTEM EVENT LOG IDENTIFIED A FAILURE IN THE AUTOMATIC MOTION CONTROL (AMC) IN THE MOTOR ASSEMBLY OF THE SYSTEM. THE FSE REPLACED THE AMC AND RELOADED THE AMC SOFTWARE TO THE SYSTEM. AFTER THE AMC WAS REPLACED, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT UP. THE DEVICE WAS NOT IN 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 722281 IS NOT SOLD IN THE USA. HOWEVER, A SIMILAR DEVICE 722228 IS MARKETED IN THE USA UNDER 510(K): K20091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335800 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