BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFIER HEATED WIRE CIRCUIT

    MDR report key: 21688 · Received May 4, 1995

    Report

    Report Number
    MW1005832
    Event Type
    Malfunction
    Date Received
    May 4, 1995
    Date of Event
    October 7, 1994
    Report Date
    April 12, 1995
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HEATED WIRE PT VENTILATOR CIRCUIT MELTED. THE PT, A PREMATURE BABY, WAS NOT AFFECTED BY THE INCIDENT. HUMIDIFIER AND CIRCUIT WERE REMOVED FROM SERVICE AND TESTED BY THE BIOELECTRONICS STAFF. DURING TESTING NEITHER THE HUMIDIFIER NOT THE PT CIRCUIT WERE FOUND FAULTY. DEVICE WAS RETURNED TO MFR FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER HEATED WIRE CIRCUIT HUMIDIFIER HEATED WIRE CIRCUIT BZO MARQUEST MEDICAL PRODUCTS, INC. SCT2000 77258

    Patients

    Seq Age Sex Outcome Treatment
    1 *