BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 16218575 · Received January 20, 2023

    Report

    Report Number
    3003768277-2023-00422
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    September 17, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085275
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING A DIAGNOSTIC CORONARY PROCEDURE AND THE PROCEDURE WAS DELAYED FOR AN HOUR. THE PROCEDURE WAS COMPLETED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT ALL THE GEOMETRY AND TABLE MOVEMENTS WERE NOT WORKING. REVIEW OF THE SYSTEM LOG FILES SHOWED GEOMETRY ERRORS. UPON FUNCTIONAL TESTING, FSE FOUND THAT THE HYBRID EXTENSION BOX (HEB) WAS FAULTY. THE FSE REPLACED THE HEB. AFTER REPLACEMENT OF THE HEB, 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 THAT THERE WAS GEOMETRY ERROR. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080475 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 3 M12 00884838085275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown