BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 1020349 · Received March 27, 2008

    Report

    Report Number
    2517967-2008-00003
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    January 19, 2008
    Report Date
    February 27, 2008
    Manufacturer
    DRAEGER MEDICAL, INC. (MT-A)
    Product Code
    BSZ
    PMA / PMN Number
    K963994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY RETAINED AN INDEPENDENT THIRD PARTY TO INSPECT THE EQUIPMENT INVOLVED IN THE REPORTED INCIDENT. DRAEGER MEDICAL WAS NOT PERMITTED TO EVALUATE THE DEVICE, HOWEVER, TWO PERSONS FROM DRAEGER MEDICAL WERE PERMITTED TO BE PRESENT FOR THE INSPECTION. THE INDEPENDENT THIRD PARTY INSPECTED AND TESTED THE AUXILIARY OXYGEN FLOWMETER ON THE NARKOMED GS ANESTHESIA MACHINE AND FOUND THAT IT FUNCTIONED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    DRAEGER MEDICAL, INC. WAS NOTIFIED VIA LETTER THAT DURING A SURGICAL PROCEDURE A FIRE OCCURRED. THE LETTER FURTHER INDICATED THAT A BOVIE AND NARKOMED GS ANESTHESIA MACHINE WERE INVOLVED. ADD'L INFO WAS OBTAINED FROM AN ATTORNEY REPRESENTING THE HOSP. REPORTED THAT DURING A TEMPORAL ARTERIAL BIOPSY PROCEDURE A FIRE OCCURRED AND THE PT SUFFERED MOSTLY FIRST AND SECOND DEGREE BURNS ON THE NOSE, LIPS AND LEFT EAR AND POSSIBLY SOME THIRD DEGREE BURNS. INDICATED THAT THE PT WAS RECEIVING OXYGEN VIA THE NARKOMED GS'S AUXILIARY OXYGEN FLOWMETER. ALSO INDICATED THAT NO ONE PRESENT DURING THE REPORTED INCIDENT ALLEGED THAT THE NARKOMED GS HAD MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. (MT-A) GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other