BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 14797991 · Received June 24, 2022

    Report

    Report Number
    3003768277-2022-00298
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 27, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE REPORTED PROBLEM. ACCORDING TO THE INFORMATION COLLECTED, MOTORIZED LONGITUDINAL MOVEMENT OF THE TABLETOP WAS NO LONGER AVAILABLE DURING THE PROCEDURE. A USER MESSAGE WAS PROMPTED TO INFORM ABOUT THE GEOMETRY ISSUE. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE AND IDENTIFIED THAT THE NODE INTERFACE UNIT (NIU) CIRCUIT BOARD WAS BURNED. THE FAILURE OF THE NIU CIRCUIT BOARD CAUSED THE BURNING SMELL AND LOSS OF TABLE MOVEMENTS. THE PHILIPS ENGINEER REPLACED THE NIU CIRCUIT BOARD AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE NIU CIRCUIT BOARD WAS SCRAPPED AND NOT AVAILABLE FOR FURTHER ANALYSIS. THE EXACT ROOT CAUSE OF THE FAILURE COULD THEREFORE NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A DIAGNOSTIC PROCEDURE THERE WAS A BURNING SMELL AND A PROBLEM WITH MOVING THE TABLE. THE USER MESSAGE ¿TABLE MOVEMENTS PARTLY AVAILABLE¿ WAS PROMPTED TO INFORM THE USER. THE PROCEDURE WAS CONTINUED IN ANOTHER ROOM. 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
    982903 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown