BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METASCOPE II

    MDR report key: 120996 · Received September 19, 1997

    Report

    Report Number
    1718663-1997-00001
    Event Type
    Malfunction
    Date Received
    September 19, 1997
    Date of Event
    September 9, 1997
    Report Date
    September 12, 1997
    Manufacturer
    COLORADO MEDTECH, INC.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE MIXING CHAMBER PLACED IN THE VENTILATOR INSPIRATORY LINE TO STABILIZE F102 SOURCE LEAKED. THIS PREVENTED THE PT FROM RECEIVING THE FULL VENTILATOR VOLUME. THE PT NEEDED TO BE MANUALLY VENTILATED. THE CAREGIVER TRIED USING A SECOND MIXING CHAMBER WITH THE DEVICE AND IT LEAKED AS WELL. AGAIN, THE PT NEEDED TO BE MANUALLY VENTILATED. THE VENTILATOR DID ALARM DURING THE INCIDENT. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASCOPE II METABOLIC PULMONARY-FUNCTION DATA CALCULATOR BZC COLORADO MEDTECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention