BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 20294343 · Received September 24, 2024

    Report

    Report Number
    3003768277-2024-05382
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 5, 2024
    Report Date
    February 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K163715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE PATIENT MOVED TO A DIFFERENT ROOM TO COMPLETE THE PROCEDURE AND THE PROCEDURE GOT DELAYED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM DID NOT EMIT X-RAYS AND GAVE ERROR MESSAGES STATING "GRID SWITCH ERROR". UPON TROUBLESHOOTING, FSE PERFORMED TUBE ADAPTATION BUT ENCOUNTERED A FAILURE WITH THE LARGE FOCUS. THE ENGINEER INSPECTED, CLEANED, AND GREASED THE HIGH-TENSION (HT) CABLES, THEN READAPTED THE SYSTEM, WHICH PASSED. HOWEVER, THE "GRID SWITCH UNAVAILABLE" MESSAGE PERSISTED. UPON CHECKING THE GRID SWITCH, IT PASSED WITH A 69 NGY READING. A FULL GENERATOR CALIBRATION, INCLUDING TUBE CONDITIONING, WAS PERFORMED, BUT THE "GRID UNAVAILABLE" MESSAGE REMAINED. THE ENGINEER CONNECTED A GRID SWITCH TEST BOX TO THE XSC, BUT THE LIGHT DID NOT ILLUMINATE. THE FSE REPLACED THE XSC, CONFIGURED THE SYSTEM, AND PERFORMED A CALIBRATION, BUT THE PROBLEM PERSISTS. REVIEW OF THE LG FILE SHOWED TUBE ARCS AND GRID SWITCH ERRORS. TO RESOLVE THE ISSUE, FSE REPLACED THE X-RAY TUBE, THE SYSTEM WAS CONFIGURED, AND A CALIBRATION WAS PERFORMED. THE DEFECTIVE X-RAY TUBE WAS RETURNED TO PHILIPS FOR FAILURE ANALYSIS AND THE CAUSE OF THE FAILURE WAS FOUND TO BE THE TUBE FAILED WITH A VACUUM LEAK AT THE CATHODE ISOLATOR. A VACUUM LEAK LEADS TO ERROR MESSAGES SHOWING GRID SWITCH FAILURES OR TUBE CURRENT BEING OUT OF RANGE. AFTER REPLACEMENT, 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 SYSTEM DID NOT EMIT X-RAYS AND GAVE ERROR MESSAGES. 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
    1870654 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