BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO ADULT VENTILATOR CIRCUIT

    MDR report key: 10455 · Received December 10, 1993

    Report

    Report Number
    MW1000078
    Event Type
    Malfunction
    Date Received
    December 10, 1993
    Date of Event
    December 8, 1993
    Report Date
    December 9, 1993
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    A HEATED WIRE MELTED THROUGH THE PLASTIC CIRCUIT. THE PT, WHO HAD UNDERGONE OPEN HEART SURGERY, WAS BEING SUCTIONED BY A RN USING A BALLARD CLOSED SUCTION CATHETER. SHE NOTICED THE LOW MINUTE VOLUME ON ANOTHER CO'S VENTILATOR GOING OFF. SHE STAT PAGED THE THERAPIST. THE PT WAS HAND VENTILATED UNTIL THE CIRCUIT WAS CHANGED. THE PT WAS EXTUBATED ON 12/9/93. THERE WAS A SIX INCH MELT POINT BACK APPROX FIVE SEGMENTS FROM THE PT "Y" ON EXPIRATORY SIDE. THE CIRCUIT WAS USED WITH THIS CO'S HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO ADULT VENTILATOR CIRCUIT BZO MARQUEST MEDICAL PRODUCTS, INC. 70516

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR