BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT BLOOD WARMER

    MDR report key: 1956737 · Received December 13, 2010

    Report

    Report Number
    1956737
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BELMONT
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER APPROXIMATELY SIX HOURS DURING OLT, THE BELMONT UNIT OVERHEATED. THE MACHINE WAS TURNED OFF AND DISCONNECTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT BLOOD WARMER BLOOD WARMER LGZ BELMONT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *