BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 2152409 · Received June 22, 2011

    Report

    Report Number
    3006697299-2011-00021
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    INTEGRA, TULLAMORE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN WAS NOT RESPONDING ON THE CUSA NXT CONSOLE. THE INTERFACE COMES UP ON THE SCREEN BUT IT DOES NOT RESPOND. THE CUSTOMER CHECKED ALL OF THE CONNECTIONS AND TRIED REBOOTING THE UNIT BUT IT WAS STILL NOT RESPONDING. THE PRODUCT PROBLEM CAUSED A DELAY OF 15 MINUTES. ALTHOUGH THERE WAS NO PT CONTACT AND A REPLACEMENT UNIT WAS AVAILABLE AND USED FOR THE PROCEDURE, INTEGRA LIFESCIENCES CORPORATION'S RISK MANAGEMENT REVIEW INDICATED THAT NOT BEING ABLE TO OPERATE THE TOUCH SCREEN AND HAVING NO RESPONSE TO THE USER INPUT WILL HAVE THE POTENTIAL EFFECT OF NOT BEING ABLE TO TREAT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA NXT CONSOLE (115-230V) ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, TULLAMORE

    Patients

    Seq Age Sex Outcome Treatment
    1