BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMETRIX

    MDR report key: 1860833 · Received September 17, 2010

    Report

    Report Number
    1860833
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE INSPIRED CO2 READINGS ARE DRIFTING ABOVE ZERO AT TIMES. TROUBLESHOOTING AT THE BEDSIDE VERIFIES THAT THE INSPIRED CO2 LEVEL SHOULD BE ZERO. WHEN THE SYSTEM IS RECALIBRATED IT WILL WORK FINE FOR ABOUT AN HOUR. NO PROBLEMS WITH THE HARDWARE HAVE BEEN FOUND BY CLINICAL ENGINEERING. GE IS STUDYING THE ISSUE WITH OUR STAFF.======================MANUFACTURER RESPONSE FOR END-TIDAL CO2 MONITOR======================THEY ARE COLLECTING INFORMATION AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMETRIX ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK GE HEALTHCARE MSNCAPCO2MOD *

    Patients

    Seq Age Sex Outcome Treatment
    1 *