BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2201168 · Received July 29, 2011

    Report

    Report Number
    1828100-2011-02269
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 29, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE UNIT WAS PUSHED UP AGAINST THE WALL AND THE ADAPTER BROKE. 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 ADAPTER DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 816426

    Patients

    Seq Age Sex Outcome Treatment
    1