BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFIER

    MDR report key: 28913 · Received December 20, 1995

    Report

    Report Number
    MW1007961
    Event Type
    Malfunction
    Date Received
    December 20, 1995
    Date of Event
    December 13, 1995
    Report Date
    December 13, 1995
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEATING WIRE INSIDE HUMIDIFIER TUBING OVER-HEATED AND CAUSED THE TUBING TO MELT THREE (3) TIMES DURING THE NIGHT. UNIT REMOVED FROM SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER HUMIDIFIER BTT MARQUEST MEDICAL PRODUCTS, INC. SCT 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DAY