BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2022977 · Received February 24, 2011

    Report

    Report Number
    1828100-2011-00391
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING FIELD SVC INSTALLATION OF THE DEVICE, THE USER REPORTED THAT THE TOUCHSCREEN DID NOT FUNCTION AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING FIELD SVC INSTALLATION OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING 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 SYSTEMS CORP. 814851

    Patients

    Seq Age Sex Outcome Treatment
    1