BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 18623866 · Received February 1, 2024

    Report

    Report Number
    3003768277-2024-00591
    Event Type
    Death
    Date Received
    February 1, 2024
    Date of Event
    January 16, 2024
    Report Date
    October 23, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION SURROUNDING THE PROCEDURE AND PATIENT OUTCOME, BUT THE CUSTOMER HAS DECLINED TO GIVE ADDITIONAL INFORMATION DUE TO LOCAL GOVERNMENT RESTRICTIONS. ONSITE INSPECTION BY A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE THIRD-PARTY UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS NOT COMPATIBLE WITH THE PHILIPS SYSTEM, NOR WAS THE ELECTRICAL INSTALLATION COMPLETED ACCORDING TO THE PHILIPS SITE PLANNING GUIDELINES. THE UPS WAS POWERING OTHER EQUIPMENT IN ADDITION TO THE PHILIPS X-RAY SYSTEM, INSTEAD OF EXCLUSIVELY POWERING THE PHILIPS SYSTEM. ADDITIONALLY, THE UPS AND ASSOCIATED OUTLETS SHOWED IMPROPER GROUNDING AND INSULATION. THE CONTROL ROOM ELECTRICAL CONTACTS WERE INCORRECTLY CONNECTED TO THE EQUIPMENT ROOM TERMINAL (ERT) CABINET. THIS NON-COMPLIANCE TRIGGERED THE ELECTRICAL NOISE AND POWER PHASE INSTABILITY OF THE UPS, CAUSING VOLTAGE DROPS DURING HIGH-POWER USE. THIS TRIGGERED THE PHILIPS X-RAY GENERATORS RECOVERY MODE. THE USER WAS PRESENTED WITH THE USER GUIDANCE (¿GENERATOR IS BUSY STARTING UP, NO X-RAY POSSIBLE¿ AND ¿RUN ABORTED: TUBE PROBLEM¿). THE SYSTEM RECOVERED AFTER 5 SECONDS, BUT SUBSEQUENT EXPOSURES WERE AGAIN ABORTED. FOLLOWING A COLD RESTART, THE ISSUE RECURRED, AND THE PROCEDURE WAS ABORTED. FURTHER INVESTIGATION CONFIRMED THAT THE ELECTRICAL INSTALLATION WAS PERFORMED BY A THIRD-PARTY CONTRACTOR. THE CUSTOMER PURCHASED THE THIRD-PARTY EATON UPS FROM THE LOCAL DISTRIBUTOR (B)(4) THEMSELVES AND ENGAGED THE SAME DISTRIBUTOR TO PERFORM THE UPS INSTALLATION. PHILIPS WAS NOT INVOLVED IN THE PURCHASE, DISTRIBUTION AND INSTALLATION OF THE THIRD PARTY UPS. TO RESOLVE THE ISSUE, THE THIRD-PARTY UPS SERVICE TEAM CONFIRMED THE SYNCHRONIZATION AND POWER PHASE ISSUES, UPDATED THE FIRMWARE, AND CALIBRATED THE POWER MODULES WHILE THE CUSTOMER CORRECTED THE GROUNDING AND WIRING ISSUES. AFTER FUNCTIONAL CHECKS, THE UPS WAS RETURNED TO CLINICAL USE. LOG FILE ANALYSIS BY PHILIPS CONFIRMED THAT THE POWER PHASE INSTABILITY TRIGGERED REPEATED RECOVERY ATTEMPTS OF THE X-RAY SYSTEM DUE TO LOSS OF SYNCHRONIZATION BETWEEN THE GENERATOR AND THE SYSTEM SOFTWARE. THE INVESTIGATION IDENTIFIED THAT THIS OCCURRED BECAUSE THE GENERATOR SOFTWARE RECEIVED CONCURRENT INTERFACE SIGNALS THAT WERE NOT PROPERLY MANAGED, RESULTING IN A COMMUNICATION FAILURE BETWEEN THE SOFTWARE AND THE GENERATOR. THE ROOT CAUSE WAS DETERMINED TO BE AN ISSUE IN THE HANDLING OF INTERFACE MESSAGES AND TIMING BETWEEN INTERNAL PROCESSES. THIS SOFTWARE ISSUE WILL BE CORRECTED IN THE UPCOMING AZURION SOFTWARE RELEASE R2.2.10. PHILIPS ADVISED THE CUSTOMER, VIA AN OFFICIAL LETTER, TO DISCONTINUE USE OF THE INCOMPATIBLE THIRD-PARTY UPS. CODING HAS BEEN UPDATED TO REFLECT INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT, WHILE IN CLINICAL USE AND AFTER SEVERAL EXPOSURES, A "GENERATOR BUSY" MESSAGE WAS DISPLAYED BY THE DEVICE PREVENTING THE FURTHER GENERATION OF X-RAYS. THE PROCEDURE WAS INTERRUPTED AND THE PATIENT MOVED TO A RECOVERY AREA FOR APPROXIMATELY TWO (2) HOURS AND WAS LATER TRANSFERRED TO A DIFFERENT FACILITY. THE PATIENT DIED TWO DAYS LATER. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383118 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 Death