BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ FLOW 480

    MDR report key: 193959 · Received October 26, 1998

    Report

    Report Number
    MW1014822
    Event Type
    Malfunction
    Date Received
    October 26, 1998
    Date of Event
    September 28, 1998
    Report Date
    September 28, 1998
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING FACILITY'S NORMAL IN-HOUSE QUALITY ASSURANCE CHECK, STAFF FOUND THAT THEY WERE UNABLE TO MOVE FROM TOTAL PARENTERAL NUTRITION TO CONTINUOUS MODE, "LLO" WAS SHOWING. PUMP WOULD NOT SCROLL UP OR DOWN EVEN IN THE TOTAL PARENTERAL NUTRITION MODE. REBOOTING THE PUMP DID NOT MAKE A DIFFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ FLOW 480 AMBULATORY INFUSION PUMP FRN GISH BIOMEDICAL, INC. 480 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other