BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 24896723 · Received April 16, 2026

    Report

    Report Number
    3003768277-2026-101057
    Event Type
    Death
    Date Received
    April 16, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 16, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099227
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT AT THE START OF AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI), THERE WAS AN ISSUE RELATED TO THE SYSTEM¿S X RAY EXPOSURE AND/OR GEOMETRY (TABLE) MOVEMENT, AND THAT PRIOR TO/SIMULTANEOUSLY WITH/AFTER THE ATTEMPT TO START THE PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC ARREST AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). CPR WAS ADMINISTERED FOR APPROXIMATELY 45 MINUTES; HOWEVER, THE PATIENT COULD NOT BE RESUSCITATED. PHILIPS HAS INITIATED AN INVESTIGATION INTO THE REPORTED COMPLAINT, WHICH, AT THIS TIME, IS STILL CHARACTERIZED BY INCOMPLETE AND/OR SEEMINGLY CONFLICTING INFORMATION. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955479 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M12 00884838099227

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death