BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1961131 · Received January 11, 2011

    Report

    Report Number
    1828100-2010-02864
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE SET OF MONITORS UNEXPECTEDLY REBOOTED THEMSELVES. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED AFTER A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1