BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 20005671 · Received August 20, 2024

    Report

    Report Number
    3003768277-2024-04495
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    August 10, 2024
    Report Date
    December 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WHILE INSERTING A CATHETER FOR AN ANGIOPLASTY PROCEDURE, THE USER MADE CONTACT WITH THE C-ARM, AND THE SYSTEM STOPPED MOVING. THE CUSTOMER REPORTED THAT THE SYSTEM REBOOT TOOK A LONG TIME, HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPORT INDICATED THAT THERE WAS A SERIOUS INJURY; HOWEVER, NO FURTHER INFORMATION REGARDING THE HARM HAS BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372240 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other