BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 1873572 · Received September 17, 2010

    Report

    Report Number
    1641965-2010-00070
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED AFTER THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    PIR - INACCURATE OUTPUT. NO OTHER INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1