BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT LINE FLUID WARMER

    MDR report key: 12687 · Received April 12, 1994

    Report

    Report Number
    MW1001546
    Event Type
    Malfunction
    Date Received
    April 12, 1994
    Report Date
    April 11, 1994
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE OVER-TEMPERATURE ALARM SOUNDED. BIOMED NOTED THAT THE BEARING RETAINER WAS LOOSE ON THE BACK OF THE PUMP MOTOR. THERE HAVE BEEN SEVERAL INCIDENTS IN THE LAST 4 MONTHS. THE WARMERS WERE PURCHASED NEW IN THE FALL OF 1993.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *