BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19296322 · Received May 13, 2024

    Report

    Report Number
    3003768277-2024-02725
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 7, 2024
    Report Date
    January 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K181830
    Removal / Correction Number
    3003768277-12/28/2023-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) INSPECTED THE SYSTEM REMOTELY AND CONFIRMED THE REPORTED EVENT. ANALYSIS OF THE LOG FILES BY RSE INDICATED A LOST CONNECTION TO INTERNAL COMPONENTS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE FLUOROSCOPY STORAGE WAS NOT POSSIBLE DUE TO AN IMAGE DISK PROBLEM. FSE IMPLEMENTED AN INTERIM SOLUTION BY REPLACING THE DISK BAY OF X-RAY PC, REINSTALLING HARD DRIVES, AND REASSEMBLING THE X-RAY PC TO RESOLVE THE ISSUE. PHILIPS HAS CONFIRMED THAT THE REPORTED FAILURE IS DUE TO A DISK BAY FAILURE. DUE TO THE DISK BAY FAILURE, THE SYSTEM MAY NOT PERFORM AS INTENDED AND MAY STOP FUNCTIONING AND IMAGING MAY NOT BE POSSIBLE, RESULTING IN DELAY OF PROCEDURE. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION (Z-1151-2024) /FIELD SAFETY CORRECTIVE ACTION (2023-IGT-BST-027). THE CORRECTION HAS BEEN SCHEDULED TO BE IMPLEMENTED ON THE SYSTEM. THE SYSTEM IS CURRENTLY BEING USED AFTER REPLACEMENT OF THE DISK BAY, REINSTALLING HARD DRIVES AND REASSEMBLING THE X-RAY PC. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED TO PROVIDE THE LINKAGE TO AN EXISTING CORRECTION & REMOVAL (3003768277-12/28/2023-010-C). THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE FIELD CORRECTION 3003768277-12/28/2023-010-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT SYSTEM WOULD NOT BOOT UP, STUCK AT SCREEN WITH PHILIPS LOGO. THE DEVICE WAS OUTSIDE OF CLINICAL 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
    438794 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown