BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 1960426 · Received December 16, 2010

    Report

    Report Number
    1641965-2010-00116
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    PUMP UNDER INFUSED/NO ALARM. PATIENT INFORMATION UNKNOWN. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    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