BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 22529275 · Received July 17, 2025

    Report

    Report Number
    3003768277-2025-006460
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    October 19, 2021
    Report Date
    July 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K162859
    Removal / Correction Number
    C&R#: 3003768277-12/28/
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-12/28/2023-011-C).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT CANNOT BE EXPOSURE. THE IS CONNECTED TO A LOSS OF LIVE IMAGE RELATED TO A ALLURA XPER FD10. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672335 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown