BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNO-FLO BAG

    MDR report key: 18730 · Received January 4, 1995

    Report

    Report Number
    MW1004656
    Event Type
    Malfunction
    Date Received
    January 4, 1995
    Date of Event
    December 17, 1994
    Report Date
    December 29, 1994
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COLOR OF CO2 PAPER WOULD NOT CHANGE COLOR FROM PURPLE. UNABLE TO DETERMINE IF TUBE WAS IN PROPER POSITION BECAUSE OF LOUD NOISE FROM EXHALATION VALVE WHICH COULD BE HEARD IN LUNGS AND ABDOMEN. ANOTHER CO2 MONITOR WOULD NOT TURN COLOR WITH THIS BAG EITHER. WHEN ANOTHER MAKE OF BAG WAS USED, THE CO2 MONITOR CHANGED COLOR AND THE PT'S COLOR BECAME PINKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNO-FLO BAG AMBU BAG BTM AMBU, INC. 94243

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR