BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 23451125 · Received November 3, 2025

    Report

    Report Number
    3003768277-2025-013788
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    February 2, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE PATIENT WAS MOVED TO ANOTHER SYSTEM AND THE WITH PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. FURTHER REVIEW IDENTIFIED THAT THIS ISSUE HAS ALREADY BEEN REPORTED VIA MFR REPORT NUMBER 3003768277-2025-013206. THIS REPORT IS BEING CLOSED AS A DUPLICATE OF MFR REPORT NUMBER 3003768277-2025-013206.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION MONITOR LOST VIDEO DURING A PROCEDURE, AND THAT THE PATIENT WAS MOVED TO ANOTHER ROOM FOR THE COMPLETION OF THE PROCEDURE. THE REPORT INDICATED THAT AN INJURY OCCURRED; HOWEVER, NO FURTHER DETAILS REGARDING THE ALLEGED INJURY HAVE BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799194 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 Other