BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 24634606 · Received March 18, 2026

    Report

    Report Number
    3042175844-2026-000223
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    January 20, 2026
    Report Date
    April 29, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT FROM AN ALREADY REPORTED COMPLAINT. THE INVESTIGATION WILL BE ADDRESSED IN MFR REPORT NUMBER 3003768277-2026-100671. THIS COMPLAINT WILL BE CLOSED AS DUPLICATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO BOOT TO THE APPLICATION, POSTPONING THE PROCEDURE. THE DEVICE WAS IN 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
    195971 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1