BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 12615338 · Received October 12, 2021

    Report

    Report Number
    3003768277-2021-10171
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 21, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K181830
    Removal / Correction Number
    Z-0476-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE REPORTED ISSUE WAS DISCOVERED OUTSIDE CLINICAL USE. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ONSITE AND REPLACED THE WIRELESS BASE STATION. PHILIPS HAS CONFIRMED THAT THE REPORTED FAILURE IS DUE TO A CONNECTIVITY ISSUE. DUE TO A FIRMWARE BUG THE WIRELESS FOOT SWITCH CAN SUDDENLY STOP RESPONDING WHEN A NUMBER OF AMBIENT CONDITIONS COEXIST, SUCH AS EMC DISTURBANCE AND THE PRESENCE OF OTHER WIRELESS DEVICES IN THE ROOM. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION (2021-IGT-BST-020). UPDATED CODES BASED ON INVESTIGATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOT PEDAL IS NOT WORKING. THE BATTERY IS FULLY CHARGED BUT CANNOT MAKE A WI-FI CONNECTION TO THE BASE UNIT. NO HARM HAS BEEN REPORTED TO PHILIPS. THE SYSTEM WAS IN CLINICAL USE PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510499 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown