BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER, THERMAL, INFUSION FLUID

    MDR report key: 17728748 · Received September 12, 2023

    Report

    Report Number
    17728748
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 21, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BELMONT INSTRUMENT, LLC
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS MORNING, DURING EMERGENCY OB CASE, RAPID INFUSER WAS ONLY WORKING INTERMITTENTLY. IT WOULD STOP RUNNING AFTER A VIEW MINUTES OF INFUSION. THE MACHINE REMAINED ON, HOWEVER, STOPPED RUNNING INTERMITTENTLY. IT WAS SWITCHED OUT WITH ANOTHER BELMONT UNIT FROM DIFFERENT OPERATING ROOM. THIS BELMONT HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642859 WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA Unknown