BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELMONT INSTRUMENT CORP

    MDR report key: 805701 · Received January 12, 2007

    Report

    Report Number
    MW1041627
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    November 14, 2006
    Report Date
    December 26, 2006
    Manufacturer
    *
    Product Code
    LGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BELMONT INSTRUMENT CORP FMS 2000 FLUID MANAGEMENT SYSTEM. (HIGH FLOW WARMER/PUMP FOR TRAUMA RESUSCITATION FLUIDS). PROBLEM: UNIT WAS ACCIDENTLY LEFT UNPLUGGED AND THE BATTERY DIED. WHEN A TRAUMA PT ARRIVED WITH SEVERE BLEEDING, THE UNIT WOULD NOT TURN ON DESPITE BEING PLUGGED INTO A GOOD OUTLET. LIFE THREATENING BLOOD PRESSURES PERSISTED FOR SEVERAL MINS BECAUSE WE COULD NOT INFUSE FLUID/BLOOD QUICKLY WITHOUT A FUNCTIONING PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT INSTRUMENT CORP FMS 2000 LGZ * FMS 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening