BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 176000 · Received July 8, 1998

    Report

    Report Number
    MW1014150
    Event Type
    Malfunction
    Date Received
    July 8, 1998
    Date of Event
    May 29, 1998
    Report Date
    July 7, 1998
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT TO MEDWATCH VOLUNTARY REPORT WITH ACCESS NUMBER 1014150, SUBMITTED ON 07/07/98: STAFF MEMBER DISCOVERED A SMALL HOLE IN THE EXPIRATORY LIMB OF THE PT CIRCUIT. THE APPROX 2" OF DANGLING WIRE (BETWEEN THE CIRCUIT AND THE HEATER BUT NOT WITHIN THE TUBING), HAD BEEN DRAPPED OVER THE EXPIRATORY LIMB, AND THE CIRCUIT APPEARS TO HAVE MELTED IN THAT VICINITY, FROM THE OUTSIDE INWARD. A STAFF MEMBER SPOKE WITH A PRODUCT MGR FROM THE MFR, WHO EXPLAINED THAT WHEN THE PT IS DISCONNECTED FROM THE CIRCUIT, THE LACK OF AIRFLOW THROUGH THE EXPIRATORY LIMB CAN RESULT IN THE WIRE HEATING UP. SHE ACKNOWLEDGED HAVING SEEN THIS PROBLEM WITH THIS PRODUCT SEVERAL TIMES IN THE PAST FEW YRS. NO NEGATIVE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INFANT HEATED WIRE CIRCUIT (VENTILATOR) BZE MARQUEST MEDICAL PRODUCTS, INC. PART # 155518 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *