BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 200

    MDR report key: 4143289 · Received September 26, 2014

    Report

    Report Number
    4143289
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 15, 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

    PUMP READS "BAG EMPTY" AND ALARMS. REPORTED TO BIOMED. FOUND INLET RESTRICTION VALVE OUT OF ADJUSTMENT. CALIBRATED VALVE, FUNCTIONAL TEST COMPLETED AND PASSED. PUMP PUT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600139 OUTLOOK 200 PUMP, INFUSION FRN B. BRAUN MEDICAL, INC. OUTLOOK 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *