BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD SIGNATURE

    MDR report key: 1083416 · Received July 20, 2008

    Report

    Report Number
    1083416
    Event Type
    Malfunction
    Date Received
    July 20, 2008
    Date of Event
    June 7, 2008
    Report Date
    July 20, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE ALARIS PUMP WAS INFUSING NORMAL SALINE WHEN THE ALARM WENT OFF DISPLAYING AN EQUIPMENT MALFUNCTION. THE EQUIPMENT WAS TURNED OFF, AND DISCONNECTED FROM THE PATIENT IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD SIGNATURE PUMP, IV FRN ALARIS MEDICAL SYSTEMS, INC. 7130EX11EE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR