BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18813998 · Received March 1, 2024

    Report

    Report Number
    3003768277-2024-01451
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 15, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION A CORONARY DIAGNOSIS PROCEDURE WAS PERFORMED WHEN THE ISSUE HAPPENED. THE PROCEDURE WAS DELAYED, AND THE PROCEDURE WAS COMPLETED WITH TIME DELAY DUE TO MOVEMENT OBSTRUCTION. THE PHILIPS FIELD SERVICE ENGINEER (FSE) ANALYZED THE SYSTEM ONSITE AND CONFIRMED THAT C-ARM PROPELLER MOVEMENT WAS NOT STABLE WITH MOVEMENT LIMITED IN THE RIGHT ANTERIOR OBLIQUE (RAO) DIRECTION. AFTER REVIEWING LOG FILE FSE DID NOT ANY GEOMETRY RELATED MALFUNCTION. UPON SOME FUNCTIONAL TEST FSE FOUND THE CAUSE OF THE ISSUE WAS LOSING BOLT WHICH FIXED SPR UNIT. FSE CHECK AND CORRECT FIXATION OF SPR UNIT, AFTER FIXATION OF SRP UNITE, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE AZURION C-ARM PROPELLER MOVEMENT WAS NOT STABLE WITH MOVEMENT LIMITED IN THE RIGHT ANTERIOR OBLIQUE (RAO) DIRECTION. THERE WAS NO REPORTED PATIENT OR USER HARM. THE DEVICE WAS REPORTEDLY IN CLINICAL USE AT THE TIME THE ISSUE OCCURRED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307119 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM. OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown