BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21085188 · Received January 6, 2025

    Report

    Report Number
    3003768277-2025-000106
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 20, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838110564
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS OUTSIDE OF USE AT THE TIME OF EVENT OCCURRENCE. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND ANALYSED THE SYSTEM LOG FILE. THE ANALYSIS OF LOG FILES IDENTIFIED GEO IO BOX (GIB) POST HAD FAILED, INDICATING A GIB FAILURE. THE CAUSE OF THE GIB FAILURE COULD NOT BE CONCLUSIVELY DETERMINED BY THE SUPPLIER'S PART ANALYSIS, HOWEVER THE REPLACEMENT OF THE GIB BY THE FIELD SERVICE ENGINEER HAS RESOLVED THE REPORTED ISSUE AND RESTORED THE FUNCTIONALITY OF THE SYSTEM. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, IT WAS IDENTIFIED THAT THE ISSUE OCCURRED WITHOUT PATIENT INVOLVEMENT AND WAS IDENTIFIABLE PRIOR TO PROCEDURE COMMENCEMENT, WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. AS PER THE INSTRUCTIONS FOR USE, THE USER OF THE PRODUCT MUST INSTITUTE A USER ROUTINE CHECKS PROGRAM. THE USER OF THE PRODUCT SHALL MAKE SURE THAT ALL CHECKS AND ACTIONS HAVE BEEN SATISFACTORILY COMPLETED BEFORE USING THE PRODUCT FOR ITS INTENDED PURPOSE. IT IS INSTRUCTED TO NOT USE THE PRODUCT FOR ANY APPLICATION UNTIL THE USER IS SURE THAT THE USER ROUTINE CHECKS HAVE BEEN SATISFACTORILY COMPLETED, THEREFORE, AS THE DEVICE WAS OUTSIDE OF USE AT THE TIME THE ISSUE WAS IDENTIFIED, THE USER WOULD IDENTIFY THIS ISSUE PRIOR TO USE. BASED ON RE-EVALUATION, THIS CASE IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE C-ARM DID NOT MOVE. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418013 AZURION AZURION 7 M20 OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M20 00884838110564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown