BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18063396 · Received November 3, 2023

    Report

    Report Number
    3003768277-2023-06011
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 27, 2023
    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
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SYSTEM WAS IN CLINICAL USE FOR A DIAGNOSIS PROCEDURE AT THE TIME OF THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH DELAY USING ANOTHER SYSTEM. A PHILIPS REMOTE SERVICE ENGINEER (RSE) INSPECTED THE SYSTEM REMOTELY AND CONFIRMED THAT IMAGE STORAGE WAS NOT POSSIBLE. ANALYSIS OF LOG FILE IDENTIFIED MALFUNCTIONING OF X-RAY PC WHICH CONFIRMED THE REPORTED PROBLEM. THE RSE INSTRUCTED THE ON-SITE FSE TO REPLACE THE DATA HARD DISK OF X-RAY PC. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND AS PART OF TROUBLESHOOTING REPLACED THE X-RAY PC, SOLID STATE DRIVE (SSD) AND HARD DISK TO RESOLVE THE ISSUE. THE REPLACEMENT OF X-RAY PC WAS FOLLOWED BY INSTALLATION OF SOFTWARE AND RESTORATION OF CONFIGURATION. THE DEFECTIVE X-RAY PC WAS RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE ANALYSIS OF X-RAY PC CONFIRMED THE MALFUNCTION OF HARD DISK DRIVE (HDD) BAY AND IDENTIFIED SLOT BUTTONS WERE NOT WORKING AS WELL AS SDD AND HDD WERE MISSING. FOLLOWING THE 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 WAS REPORTED TO PHILIPS THAT NO IMAGE MEMORY WAS AVAILABLE ON THE AZURION SYSTEM. THE DEVICE WAS INSIDE OF CLINICAL USE AT THE TIME OF THE 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
    2092235 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