BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22103381 · Received May 29, 2025

    Report

    Report Number
    3003768277-2025-004861
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 16, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099265
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 PROCEDURE WAS COMPLETED BY USING ANOTHER SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND IDENTIFIED THAT ISSUES ASSOCIATED WITH SUITE PC. THE REVIEW OF SYSTEM LOG FILE INDICATED ISSUE RELATED TO SOFTWARE. TO RESOLVE THIS ISSUE, THE FSE REPLACED THE SUITE PC AND SDD(HARD DISK DRIVE) AND RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE ANALYSIS IDENTIFIED THE SDD COMPONENT WAS MISSING IN THE SUITE PC. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION'S OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS HANGED DURING MID OF THE PROCEDURE.THE DEVICE WAS IN USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994085 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838099265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown