BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 14654166 · Received June 10, 2022

    Report

    Report Number
    3003768277-2022-00278
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 13, 2022
    Report Date
    January 3, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K172822
    Removal / Correction Number
    3003768277- 2021/10/29-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INFORMATION COLLECTED, THE WI-FI INDICATOR ON THE FOOTSWITCH WAS RED, WHICH INDICATES THAT THERE WAS AN ERROR IN THE WIRELESS CONNECTION. THE CUSTOMER IS CURRENTLY USING THE WIRED FOOTSWITCH INSTEAD OF THE WIRELESS 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.

    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 THERE WAS A PROBLEM WITH THE WIRELESS FOOTSWITCH. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. NO HARM HAS BEEN REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725283 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