BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21275580 · Received January 30, 2025

    Report

    Report Number
    3003768277-2025-000868
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    July 21, 2022
    Report Date
    January 30, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099265
    PMA / PMN Number
    K200917
    Removal / Correction Number
    C&R#: 3003768277-12/08/2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 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#: 3003768277-12/08/2023-009-C.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT " THE X-RAY PEDAL CABLE IS DAMAGED". THIS IS CONNECTED TO A LOSS OF IMAGE RELATED TO A ALLURA XPER FD20/10 & FD20/20. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506293 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838099265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown