BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 2061468 · Received March 16, 2011

    Report

    Report Number
    1641965-2011-00018
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 16, 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
    BIOMEDICAL ENGINEER

    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

    DISPLAY SHOWS THAT THE PUMP IS RUNNING BUT IT IS NOT. BIOMED STATED THAT PT WAS PROBABLY OK. FORM THE BIOMED'S SERVICE TICKET: PUMP LOOKED LIKE IT WAS PUMPING AND IT WAS NOT/SHOWN ON DISPLAY/SHRILL BEEPING NOISE/NO ERROR MESSAGE ON SCREEN/LABOR AND DELIVERY DEPT/CONTINUOUS THERAPY.

    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