BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 23393532 · Received October 27, 2025

    Report

    Report Number
    3003768277-2025-013206
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 22, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED AND COMPLETED BY MOVING THE PATIENT TO ANOTHER ROOM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND IDENTIFIED THAT THE FLEXVISION MONITOR REPEATEDLY TURNING ON AND OFF. UPON TROUBLESHOOTING ACTIONS, THE FSE IDENTIFIED THAT THE RGB MEDIA WALL CAUSED THE MONITOR TO LOSE ITS PICTURE. THE FSE REPLACED THE RGB MEDIA WALL IN ANOTHER CASE. AFTER REPLACEMENT, 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'S FLEXVISION MONITOR KEPT TURNING OFF AND ON, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2740754 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown