BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOFLEX LF

    MDR report key: 1862524 · Received September 17, 2010

    Report

    Report Number
    1862524
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE PORTION OF THE SIDE STREAM CO2 CLOGS WITHIN 24 HOURS OF USE. THE PRODUCT IS COSTLY TO REPLACE THAT FREQUENTLY AND INTERRUPTS THE MONITORING AND TRENDING OF DATA. THIS SYSTEM DOES NOT HAVE A WATER TRAP, REPLACEABLE NAFION TUBING, OR REPLACEABLE FILTERS.======================MANUFACTURER RESPONSE FOR GE ETCO2 SIDE STREAM TUBING SET======================NO RESPONSE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOFLEX LF AIRWAY ADAPTER KIT WITH DEHUMIDIFICATION TUBING BYX GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *