BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL RESPIRATORY HEATED WIRE CIRCUIT

    MDR report key: 592673 · Received February 16, 2005

    Report

    Report Number
    592673
    Event Type
    Malfunction
    Date Received
    February 16, 2005
    Date of Event
    January 12, 2005
    Report Date
    February 2, 2005
    Manufacturer
    MARQUEST MEDICAL PRODUCTS INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LOW MINUTE VOLUME ALARMED, THE GRAPHICS OF THE VENTILATOR SHOWED THERE WAS A LEAK. THE ALARM KEPT GOING OFF THROUGHOUT THE NIGHT. RESPIRATORY THERAPIST RAN A CHECK IN THE MORNING AND NOTED A HOLE IN THE EXHALATION TUBING NEAR THE VENTILATOR. THE CIRCUIT WAS CHANGED AND THE PROBLEM RESOLVED. THIS EVENT POSSIBLY CONTRIBUTED TO PROLONGED VENTILATION OF THE PATIENT. UNABLE TO DETERMINE IF THIS INCIDENT HAD ANY EFFECT ON THE PATIENT. SLIGHT BLOOD GAS CHANGES WERE NOTED. THERE WAS NOT MUCH CHANGE IN THE PATIENT'S RATE. FI02 WAS CHANGED, INCREASED SLIGHTLY. THE PATIENT WAS WEANED DOWN TO ROOM AIR ONCE TUBING WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL RESPIRATORY HEATED WIRE CIRCUIT VENTILATOR CIRCUIT CBK MARQUEST MEDICAL PRODUCTS INC UNK UNK
    2 SIEMENS SERVO VENTILATOR 300I VENTILATOR CBK MAQUET INC SIEMANS 300I VENTILATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DAY