BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18421766 · Received December 29, 2023

    Report

    Report Number
    3003768277-2023-07266
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    November 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER (FSE) PERFORMED FUNCTIONAL ANALYSIS AND CONFIRMED THAT THE CASE WAS OPENED TO CORRECT AN FCO IF ANY PROBLEM OCCURS. FSE FURTHER CONFIRMED THAT THERE WAS NO FCO FAILURE AND THERE WAS ANOTHER CASE HAS BEEN CREATED TO IMPLEMENT THE FCO. NO SERVICE HAS BEEN PERFORMED BY PHILIPS AS NO FAILURE WAS IDENTIFIED. TO DATE, NO FURTHER INFORMATION WAS RECEIVED. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRELESS FOOT SWITCH FAILED. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240602 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