BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGM ANESTHETIC GAS MODULE

    MDR report key: 1990005 · Received February 1, 2011

    Report

    Report Number
    1990005
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    November 19, 2010
    Report Date
    February 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION OF THE PATIENT, IT WAS NOTED THAT THE CO2 MONITOR WAS NOT WORKING. THE PATIENT HAD A DIFFICULT AIRWAY AND THE ANESTHESIOLOGIST WAS UNABLE TO DETERMINE PROPER PLACEMENT OF THE ET TUBE.CLINICAL ENGINEERING FOUND AN INTERNAL SAMPLING LINE TO BE OCCLUDED.--------------------------------------------ANESTHESIOLOGIST TECHNICIANS WERE CALLED INTO THE ROOM. DR'S ASSISTANCE WAS REQUESTED AND THE EQUIPMENT WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGM ANESTHETIC GAS MODULE GAS MONITOR CCK PHILIPS HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR