BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 200

    MDR report key: 4143285 · Received September 26, 2014

    Report

    Report Number
    4143285
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    March 11, 2014
    Report Date
    September 26, 2014
    Manufacturer
    B BRAUN MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    REPORTED TO BIOMED THAT PUMP NOT WORKING. ENGINEER EVALUATED PUMP AND FOUND CONSTANT OCCLUSION ALARM; CLEANED AND LUBRICATED OUTLET RESTRICTION VALVE. FUNCTIONAL TEST COMPLETED AND PASSED. PUMP PUT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599929 OUTLOOK 200 INFUSION PUMP FRN B BRAUN MEDICAL, INC. OUTLOOK 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *