BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 23530403 · Received November 12, 2025

    Report

    Report Number
    3003768277-2025-014483
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 20, 2025
    Report Date
    January 29, 2026
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED DURING VASCULAR PROCEDURE PROCEED WHEN THE ISSUE HAPPENED. THE PATIENT WAS MOVED TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. PHILIPS FSE INSPECTED THE SITE AND FOUND THE FLEX VISION MONITOR'S BOTTOM HALF WENT BLANK, FOLLOWED BY THE ENTIRE SCREEN. FSE IDENTIFIED ISSUE WITH RGB MEDIA WALL OF THE MONITOR. TO RESOLVE THE ISSUE FSE REPLACED MEDIA WALL. AFTER REPLACEMENT OF RGB MEDIA WALL, 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 WAS UNABLE TO DISPLAY THE LIVE IMAGE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543912 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