BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD

    MDR report key: 23559634 · Received November 14, 2025

    Report

    Report Number
    3003768277-2025-014615
    Event Type
    Death
    Date Received
    November 14, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 14, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059030
    PMA / PMN Number
    K130842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING A DIAGNOSTIC CORONARY ANGIOGRAPHY, THE FLEXVISION MONITOR FROZE. A COLD SYSTEM RESTART RESOLVED THE REPORTED ISSUE. THE REPORT INDICATED THAT THE PATIENT PASSED AWAY. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715153 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death