BEUDAMED
    FDA Adverse Event Other Summary report: N

    NARKOMED

    MDR report key: 676520 · Received February 13, 2006

    Report

    Report Number
    2517967-2006-00032
    Event Type
    Other
    Date Received
    February 13, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 9, 2006
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE MACHINE IS NOT USED FREQUENTLY FOR GENERAL ANESTHESIA CASES. THE ABSORBENT MATERIAL IS NORMALLY REPLACED ONCE A WEEK. THE FACILITY USES SODASORB FOR THE ABSORBENT MATERIAL. THE USER OBSERVED HIGH READINGS FOR CO2 AND LOW AGENT READINGS DURING THE CASE. APPROX HALF OF THE AGENT THAT WAS SET WAS BEING DELIVERED. AFTER THE CASE, THE PT WAS REPORTED TO HAVE RECALL OF THE PROCECDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. 6400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other