BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 1170802 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00285
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    HOSPIRA, INC
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE DEVICE DELIVERED LESS FLUID THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW MODEL 4000 PLUS 80-FRN FRN HOSPIRA, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA