BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI

    MDR report key: 1010545 · Received February 20, 2008

    Report

    Report Number
    1010545
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 20, 2008
    Manufacturer
    IMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE PUMP ALARM WENT OFF. THE ERROR MESSAGE READ "HELP-INTERNAL FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PUMP, IV FRN IMED CORPORATION PC2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR