BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 12376673 · Received August 27, 2021

    Report

    Report Number
    3003768277-2021-10073
    Event Type
    Death
    Date Received
    August 27, 2021
    Date of Event
    August 15, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K181830
    Removal / Correction Number
    Z-0476-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. WHEN A PROCEDURE IS ALREADY IN PROGRESS AND THE WIRED FOOTSWITCH IS CONNECTED, A SYSTEM RESTART IS REQUIRED FOR THE WIRED FOOTSWITCH TO BE RECOGNIZED. PHILIPS INFORMED THE CUSTOMER TO KEEP THE WIRED FOOTSWITCH CONNECTED SO THAT A RESTART IS NOT REQUIRED IF THE WIRED FOOTSWITCH IS NEEDED. A PHILIPS SERVICE ENGINEER REPLACED THE WIRELESS FOOTSWITCH AND 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 DURING A PRIMARY INTERVENTION, THE WIRELESS X-RAY FOOT PEDAL OPERATION FAILED, AND THE SYSTEM BECAME UNRESPONSIVE. A WIRED FOOTSWITCH WAS CONNECTED BUT THE SYSTEM REMAINED UNRESPONSIVE UNTIL IT WAS RE-BOOTED. FOLLOWING REBOOT NORMAL FUNCTIONING WAS RESUMED WITH THE WIRED PEDAL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CRITICALLY ILL PATIENT PASSED AWAY. THE CUSTOMER DIDN'T THINK THE DEATH WAS AN OUTCOME OF THE FAILURE. A DEATH HAS BEEN REPORTED TO THE CORONER. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274221 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death