BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 805927 · Received January 12, 2007

    Report

    Report Number
    2517967-2007-00001
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    November 24, 2004
    Report Date
    November 24, 2004
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K963994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER MEDICAL, INC. WAS NOT MADE AWARE OF THE REPORTED ADVERSE EVENT AT THE TIME IT ALLEGEDLY OCCURRED. WHEN DRAEGER MEDICAL, INC. WAS SERVED WITH THE AMENDED COMPLAINT, AN ATTEMPT WAS MADE TO SPEAK TO A HOSPITAL BIOMED REPRESENTATIVE. THE BIOMED WAS ASKED IF THEY WERE AWARE OF THE REPORTED EVENT, AND THEY ANSWERED YES. THEY WERE THEN ASKED IF THEY LOOKED AT THE DEVICE AFTER THE REPORTED EVENT, AND WHETHER THE DEVICE WAS STILL IN USE. THE ANSWER GIVEN WAS THAT THEY DID NOT THINK THEY SHOULD ANSWER ANY QUESTIONS INVOLVING THE REPORTED EVENT WITHOUT SPEAKING TO THEIR LEGAL DEPARTMENT. IT WAS EXPLAINED THAT DRAEGER MEDICAL, INC. WAS ONLY TRYING TO OBTAIN INFORMATION TO DETERMINE WHETHER THE REPORTED EVENT SHOULD BE REPORTED IN ACCORDANCE WITH FDA REGULATIONS. THE REPLY WAS THAT THEY COULD NOT ANSWER ANY QUESTIONS PERTAINING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    ON NOVEMBER 22, 2006, DRAEGER MEDICAL, INC. WAS SERVED WITH AN AMENDED COMPLAINT FILED IN THE COURT. IN THE AMENDED COMPLAINT, IT WAS ALLEGED THAT A PATIENT, WHILE UNDERGOING AN ELECTIVE SURGICAL REPAIR OF AN ACQUIRED NASAL DEFECT, SUFFERED BURNS TO THE FACE, THROAT AND AIRWAY AS A RESULT OF AN OXYGEN FIRE THAT OCCURRED WHEN A DOCTOR WAS USING A BOVIE ELECTROCAUTERY DEVICE ON THE PATIENT'S CHEEK AND RIGHT SIDE OF THE NOSE. IN THE COMPLAINT, THE PLAINTIFF ALLEGES THAT THE ANESTHESIOLOGIST CLAIMED THAT ALTHOUGH THE AUXILIARY OXYGEN FLOWMETER WAS TURNED OFF, OXYGEN CONTINUED TO FLOW AT A RATE OF 1-2 LITERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other