BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 16149253 · Received January 12, 2023

    Report

    Report Number
    3003768277-2023-00260
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 5, 2023
    Report Date
    October 10, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K163715
    Removal / Correction Number
    3003768277- 2021/10/29-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PER THE INFORMATION COLLECTED, THE WI-FI INDICATOR ON THE FOOTSWITCH WAS BLINKING RED WHICH INDICATES THAT THERE WAS AN ERROR IN THE WIRELESS CONNECTION. THE CONNECTION WAS NOT RE-ESTABLISHED. 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 (Z-0476-2022). THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. (DEVICE) PROBLEM ,EVALUATION METHOD AND CONCLUSION CODES WERE CORRECTED.

    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. THE PRODUCT UDI, REPORTING INSTITUTION NAME, REPORTING ADDRESS LINE 1 AND THE REPORTING ADDRESS CITY HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH HAS CONNECTION ISSUES. THE SYSTEM WAS NOT IN CLINICAL USE AND NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535184 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown