BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 100 MONITOR

    MDR report key: 1913425 · Received November 12, 2010

    Report

    Report Number
    1828100-2010-02186
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 12, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED UPON TURNING ON THE DEVICE, THE SCREEN TURNED BLUE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 100 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 100

    Patients

    Seq Age Sex Outcome Treatment
    1