BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2182670 · Received July 5, 2011

    Report

    Report Number
    1828100-2011-01890
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT WHEN TRYING TO RUN A QUERY A "FIELD PROCEDURE ALREADY EXISTS IN TABLE CASEDATA1" ERROR MESSAGE OCCURRED. THE SOFTWARE THEN CREATED A DUPLICATE FILE THAT COULD NOT BE DELETED. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, 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 SYSTEM CORP 814850

    Patients

    Seq Age Sex Outcome Treatment
    1