BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 22990987 · Received September 8, 2025

    Report

    Report Number
    3003768277-2025-009200
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    November 25, 2021
    Report Date
    September 8, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS SERVICE REPLACED THE NEHALEM HOST PC MONOPLANE REV_III NO_HDD AND 19" COLOR LCD MONITOR ER (DC19-LER), RESTORING THE SYSTEM TO OPERATIONAL USE. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM INTERMITTENTLY FAILED TO START; HOST PC AND MONITOR REPLACED ON A ALLURA XPER FD20. THE CLINICAL USE OF THE SYSTEM WAS OUTSIDE OF USE. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915286 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown