BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 16512941 · Received March 9, 2023

    Report

    Report Number
    3003768277-2023-01321
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 27, 2023
    Report Date
    December 12, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085367
    PMA / PMN Number
    K163715
    Removal / Correction Number
    3003768277- 2021/10/29-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON SITE AND FOUND THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING PROPERLY. PER THE INFORMATION COLLECTED, THE WIRELESS FOOTSWITCH DID NOT CONNECT TO ITS BASE STATION. THE CONNECTION WAS RE-ESTABLISHED AND THE CONNECTION FAILURE IN THE WIRELESS FOOTSWITCH HAS BEEN RESOLVED WITH A SOFTWARE UPDATE. INTERMITTENTLY THE WIRELESS CONNECTION BETWEEN THE BASE STATION AND WIRELESS FOOTSWITCH IS LOST AND THE BASE STATION OR FOOTSWITCH REMAINS IN ERROR MODE. WHEN THE BASE STATION OR FOOTSWITCH IS IN ERROR MODE IT BLOCKS X-RAY SWITCHING FUNCTIONS BY MEANS OF THE WIRELESS FOOTSWITCH. OTHER OPTIONS LIKE THE WIRED FOOTSWITCH OR HAND SWITCH CAN STILL BE USED WHEN AVAILABLE. THIS ISSUE IS PRESENT IN THE FIRMWARE OF THE WIRELESS FOOTSWITCH PARTS, RELEASED WITH ECR-041999. FSE FOUND WIRELESS FOOTSWITCH HAS BROKEN SCREWS AT THE BOTTOM AND REPLACED IT (Z-0476-2022). THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    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 WORKING. THE ISSUE WAS FOUND DURING CLINICAL USE. 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
    659294 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838085367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown