BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2240846 · Received August 16, 2011

    Report

    Report Number
    1828100-2011-02462
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 16, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    JUST PRIOR TO THE ONSET OF CARDIOPULMONARY BYPASS, THE USER REPORTED THE TOUCH SCREEN WOULD NOT RESPOND. THE USER WAS ONLY ABLE TO ACCESS CASE PROPERTY INFO BY USING AN EXTERNAL MOUSE AND KEYBOARD. THE SYSTEM WAS REBOOTED AND THE TOUCH SCREEN WORKED AGAIN. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-LINK DATA MANAGEMENT SYSTEM PERFUSION LIBRARY SOFTWARE DWA TERUMO CARDIOVASCULAR SYSTEM CORP. 814851

    Patients

    Seq Age Sex Outcome Treatment
    1