BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER APOLLO

    MDR report key: 1151945 · Received September 5, 2008

    Report

    Report Number
    MW5008215
    Event Type
    Other
    Date Received
    September 5, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 5, 2008
    Manufacturer
    NORTH AMERICAN DRAEGER
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DRAEGER ANESTHESIA MACHINE, MODEL APOLLO. GAS SAMPLE LINE WATER TRAP PLUGGED CAUSING ETCO2 TO GO TO UNACCEPTABLE LEVEL. REPEATED INTERMITTENT ALARMS "SAMPLE LINE PLUGGED" WERE NOT RESOLVED PRIOR TO PROBLEM, ALTHOUGH LABELING OF ALARM WAS MISLEADING. MACHINE SWAPPED IN USE, NO NOTED PT. ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER APOLLO ANESTHESIA MACHINE BSZ NORTH AMERICAN DRAEGER APOLLO

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other