BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 2081076 · Received April 14, 2011

    Report

    Report Number
    1641965-2011-00025
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    PIR - UNDER INFUSION. SHOWS IT IS RUNNING BUT NOT INFUSING ANYTHING, DOES NOT GIVE ANY ALARM INDICATING IT IS NOT ACTUALLY MOVING ANY FLUIDS. EVEN WHEN TUBING IS REMOVED IT STILL SHOWS IT IS RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK