BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID MANAGEMENT SYSTEM

    MDR report key: 490546 · Received October 17, 2003

    Report

    Report Number
    1219702-2003-00003
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    September 16, 2003
    Report Date
    October 16, 2003
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIOLOGIST WAS USING THE SYSTEM FOR APPROX 1 HOUR, THEN THE SYSTEM STOPPED WORKING. THE BIOMEDICAL ENGINEER TRIED TO RESTART BUT IT WOULD NOT TURN ON. THE SYSTEM WAS CHANGED OUT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID MANAGEMENT SYSTEM INFUSION PUMP WITH WARMER FRN BELMONT INSTRUMENT CORP. FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other