BEUDAMED
    FDA Adverse Event Summary report: N

    HOTLINE FLUID/BLOOD WARMER

    MDR report key: 11830 · Received March 3, 1994

    Report

    Report Number
    MW1000949
    Date Received
    March 3, 1994
    Date of Event
    January 21, 1994
    Report Date
    March 1, 1994
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    LGZ
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AFTER THE "OVER TEMP" MESSAGE ALARMED, THE WATER PUMP BEGAN MAKING EXCESSIVE NOISE. UPON INSPECTION, IT WAS NOTED THAT THE BEARING IN THE PUMP MOTOR HAD BROKEN LOOSE ALLOWING THE SHAFT TO WANDER. THERE WERE NO INCIDENTS INVOLVING 2 DIFFERENT DEVICES. ADD'L EVENT DATE SHOWN OF 2/16/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOTLINE FLUID/BLOOD WARMER LGZ LEVEL 1 TECHNOLOGIES, INC. HL-90

    Patients

    Seq Age Sex Outcome Treatment
    1 *