BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE PORTABLE

    MDR report key: 1183945 · Received October 1, 2008

    Report

    Report Number
    MW5008498
    Event Type
    Injury
    Date Received
    October 1, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    COLUMBIA ANCILLARY SERVICES, INC.
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING A PORTABLE OXYGEN TANK WITH THE O2 DELIVERED VIA NASAL CANNULA WHEN "VAPOR" STARTED COMING OUT AROUND THE TUBING. PATIENT SUFFERED BURNS TO NECK, FACE AND NOSE REQUIRING MEDICAL TREATMENT. BACITRACIN TO BURNS ON FACE AND SILVADENE TO BURNS ON NECK. O2 TANK FILLED BY CNA - NOT LEAKING, NO VAPOR ESCAPING, NO FREEZING NOTED. LPN TURNED TANK ON AT 2 L VIA N/C. NO LEAKING NOTED. APPROXIMATELY 45 MINUTES LATER, RESIDENT PROVIDED ICE CREAM BY CNA. NO PROBLEMS NOTED WITH O2 AT THAT TIME. A FEW MINUTES LATER, CNA FOUND O2 TUBING FROZEN, TANK BUBBLING, FROZEN, AND RESIDENT WITH BURNS ON FACE AND NECK. O2 TANK IMMEDIATELY REMOVED AND SENT TO MAINTENANCE DEPARTMENT. RESIDENT EVALUATED AND TREATED OVERNIGHT AT HOSPITAL. IN 2008, TANK RETURNED FOR INSPECTION. STAFF REPORT THAT O2 SECURED ON BACK OF WHEELCHAIR IN UPRIGHT POSITION. DOSE OR AMOUNT: 2 LITERS; FREQUENCY: CONTINUOUS; ROUTE: NC. DATES OF USE: 2007 TO PRESENT. SUSPECT STROLLER USED 2080. DIAGNOSIS OR REASON FOR USE: COPD. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE PORTABLE OXYGEN STROLLER ECX COLUMBIA ANCILLARY SERVICES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention