BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21772019 · Received April 4, 2025

    Report

    Report Number
    3003768277-2025-003092
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 24, 2025
    Report Date
    July 21, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PLANED TREATMENT PROCEDURE WAS PERFORMED WHEN THE ISSUE HAPPENED. THE PROCEDURE WAS COMPLETED AS PLANNED ON THE SAME SYSTEM. A PHILIPS REMOTE SERVICE ENGINEER CONTACTED THE CUSTOMER AND FOUND THAT THE SYSTEM SHOWED A MESSAGE ABOUT THE GENERATOR RESTARTING, THEN POOR IMAGE QUALITY. AFTER REVIEWING THE LOG FILE, FOUND TUBE ARCING ERRORS. UPON TROUBLESHOOTING, ONSITE VISIT, FSE FOUND BOTH THE ANODE AND CATHODE TO BE CLEAN, AND THE HI-VOLTAGE END SHOWED SEVERE BURNING AND BLACKENING OF THE CATHODE CANDLE FROM ARCING, CAUSING ADDITIONAL DAMAGE TO HI VO COMPONENTS. TO RESOLVE THE PROBLEM, FSE REPLACED THE HT CABLE AND THE HI VO UNIT AND RETURN THE PART FOR FURTHER ANALYSIS AND IT FOUND THE HIGH VOLTAGE TRANSFORMER IS ELECTRICALLY DEFECTIVE, SHOWING CHARRING AT THE O3 CONNECTOR'S ANODE SIDE LIKELY DUE TO POLLUTION CAUSING ARCING. AFTER REPLACEMENT OH HV CABLE AND HI VOLT TRANSFORMER, 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 A POTENTIAL FOR SERIOUS INJURY AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS BEEN RECEIVED 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 INFORMATION RECEIVED THE PROCEDURE WAS NOT AFFECTED, AND THE CUSTOMER WAS ABLE TO COMPLETE AS PLANNED TO USE THE SAME SYSTEM WITH NO OR MINIMUM DELAY, IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT RECUR. THEREFORE, BASED ON THIS INVESTIGATION RESULTS, PHILIPS CONCLUDES THAT THIS COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM EXPOSURE. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323376 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown