BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21962876 · Received May 5, 2025

    Report

    Report Number
    3003768277-2025-004091
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 15, 2025
    Report Date
    June 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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 3003768277-2025-004037. 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. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE 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
    443435 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