BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS

    MDR report key: 395909 · Received May 22, 2002

    Report

    Report Number
    MW1025112
    Event Type
    Malfunction
    Date Received
    May 22, 2002
    Date of Event
    May 10, 2002
    Report Date
    May 16, 2002
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MECHANICAL VENTILATION INITIATED IN MAY 2002. FOUR DAYS LATER, TWENTY MINUTES AFTER CHECKED THE VENTILATOR, NURSE NOTICED A BURING SMELL AND SMOKE COMING FROM THE VENTILATOR TUBING. THE VENTILATOR WAS SHUT OFF, UNPLUGGED AND REMOVED FROM SERVICE. UPON EXAMINATION THE INSPIRATORY HEATED WIRE WAS MELTED AT THE CONNECTION TO THE SPLITTER OF THE CONNECTION TO THE SPLITTER OF MARQUEST STC3000 HEATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS HEATED WIRE VENTILATOR CIRCUIT CAI MARQUEST MEDICAL PRODUCTS, INC. * 582T

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR