BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ FLOW 480

    MDR report key: 193963 · Received October 26, 1998

    Report

    Report Number
    MW1014823
    Event Type
    Malfunction
    Date Received
    October 26, 1998
    Date of Event
    September 26, 1998
    Report Date
    September 26, 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

    UPON PERFORMING FACILITY'S USUAL QA TESTING PRIOR TO SENDING THE PUMP TO ANOTHER PT, STAFF FOUND THAT THEY WERE UNABLE TO CHANGE THE NUMBER VALUES ON THE SCREEN. PUMP WAS IN "LLO". PUMP WAS REBOOTED. STILL UNABLE TO CHANGE NUMBER VALUES.

    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