BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED WIRE CIRCUIT (VENT HUMIDIFIER)

    MDR report key: 5017630 · Received August 20, 2015

    Report

    Report Number
    5017630
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    November 9, 2014
    Report Date
    July 7, 2015
    Manufacturer
    VITAL SIGNS COLORADO INC.
    Product Code
    BZE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEATED WIRE CIRCUIT MELTED THROUGH A 6 INCH SECTION OF VENTILATOR TUBING, CAUSING A LEAK IN THE LINE. THE NURSE MANUALLY VENTILATED THE PATIENT UNTIL THE PROBLEM WAS FIXED. THE PATIENT DID NOT EXPERIENCE ANY DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552270 HEATED WIRE CIRCUIT (VENT HUMIDIFIER) BZE VITAL SIGNS COLORADO INC. 155518

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR HEATER/HUMIDIFIER: MARQUEST 3000 ST