BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE

    MDR report key: 3848482 · Received May 21, 2014

    Report

    Report Number
    2112667-2014-00082
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT, DURING A CASE, THE CLINICIAN WAS DELIVERING 6 LPM OF OXYGEN (O2). THE CLINICIAN THEN PLACED A LARYNGEAL MASK AIRWAY AND CHANGED O2 FLOW TO 3 LPM. AT SOME POINT, A FIRE OCCURRED WHILE USING A CAUTERY DEVICE. THE PT REPORTEDLY INCURRED FIRST AND SECOND DEGREE BURNS. SILVADENE BURN CREAM WAS APPLIED TO THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303400 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention