BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 13107922 · Received December 29, 2021

    Report

    Report Number
    3003768277-2021-10292
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 9, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099241
    PMA / PMN Number
    K200917
    Removal / Correction Number
    3003768277- 2021/10/29-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION PROVIDED, THE WIRELESS FOOTSWITCH LOST IS CONNECTION TO THE BASE STATION DURING A CORONARY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE WIRED FOOTSWITCH. 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).

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED TO PROVIDE THE LINKAGE TO AN EXISTING CORRECTION & REMOVAL (3003768277- 2021/10/29-004-C). THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE CORRECTION & REMOVAL 3003768277- 2021/10/29-004-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT CONNECTING, AND THE WIFI INDICATOR WAS RED. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT CONNECTING, AND THE WIFI INDICATOR WAS RED. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004536 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838099241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown