BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOTLINE FLUID WARMER

    MDR report key: 24849 · Received August 23, 1995

    Report

    Report Number
    MW1006759
    Event Type
    Malfunction
    Date Received
    August 23, 1995
    Date of Event
    January 1, 1995
    Report Date
    August 18, 1995
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN TIPPED, WATER RESERVOIR BECOMES CONTAMINATED WITH NUMEROUS GRAM NEGATIVE ROOS WHICH CAN BE DISTRIBUTED TO THE ENVIRONMENT (AND THEREFORE, POTENTIALLY, TO PTS). PRODUCT INSTRUCTION MATERIALS ARE UNCLEAR REGARDING PROPER DISINFECTION OR DECONTAMINATION INTERVALS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *