BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID INFUSER

    MDR report key: 1515322 · Received October 15, 2009

    Report

    Report Number
    1515322
    Event Type
    Malfunction
    Date Received
    October 15, 2009
    Date of Event
    September 27, 2009
    Report Date
    October 15, 2009
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE RAPID INFUSER STOPPED WORKING WHILE INFUSING FLUID AND BLOOD TO A TRAUMA PATIENT.

    Description of Event or Problem · 1

    THE RAPID INFUSER STOPPED WORKING WHILE INFUSING FLUID AND BLOOD TO A TRAUMA PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID INFUSER INFUSION PUMP FRN BELMONT INSTRUMENT CORPORATION FMS2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR