BEUDAMED
    FDA Adverse Event Other Summary report: N

    NARKOMED

    MDR report key: 587926 · Received March 30, 2005

    Report

    Report Number
    2517967-2005-00046
    Event Type
    Other
    Date Received
    March 30, 2005
    Date of Event
    March 17, 2005
    Report Date
    March 17, 2005
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE CASE, THE USER PERFORMED THE LEAK AND COMPLIANCE TESTS AND THE MACHINE PASSED. DURING THE CASE, THE USER OBSERVED THAT THE DEVICE WAS PROVIDING A SEVOFLURANE READING OF 1% NO MATTER IF THE SETTING WAS INCREASED. THE CONDITION WAS OBSERVED IN BOTH MANUAL AND AUTOMATIC VENTILATION. THE USER WAS UNABLE TO RETAIN PRESSURE IN MANUAL MODE. THE BIOMED REPLACED THE APL VALVE DURING THE PRECEDURE AND STATED THAT THE DEVICE FUNCTIONED NORMALLY. THE USER COMPLETED THE CASE USING THE DEVICE. NO PATEINT INJURY. AFTER THE CASE, THE BIOMED TESTED THE MACHINE. THE BIOMED REMOVED THE FRESH GAS HOSE AND WAS TESTING THE SYSTEM AND BELIEVE THAT A LEAK WAS PRESENT AND RELATED TO THE VAPORIZERS. THE BIOMED RESEATED THE THIRD VAPOR POSITION AND THE DEVICE FUNCTIONED NORMALLY. THE BIOMED TESTED THE REPLACED APL VALVE AND THE VALVE FUNCTIONED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED CONTINUOUS VENTILATOR BSZ DRAEGER MEDICAL, INC. 6000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN