BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE OXYGEN CONCENTRATORS

    MDR report key: 1000021 · Received February 14, 2008

    Report

    Report Number
    1525712-2008-00010
    Event Type
    Death
    Date Received
    February 14, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 11, 2008
    Manufacturer
    INVACARE RESPIRATORY PRODUCTS
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED A MEDWATCH REPORT COPY. FACILITY REPORTS THE CONSUMER HAD BEEN EDUCATED REGARDING THE DANGERS OF SMOKING WHILE ON HOME OXYGEN. PT REPORTEDLY ATTEMPTED TO LIGHT A CIGARETTE WHILE USING AN OXYGEN CONCENTRATOR MFR BY INVACARE. USER REPORTEDLY BURNED HIS HEAD, FACE, AND ARMS AS THE RESULT OF SMOKING, WHILE USING MFR'S CONCENTRATOR. USER WAS TRANSPORTED TO A HOSP REPORTEDLY HAD DIFFICULTIES BREATHING. PATIENT EXPIRED DUE TO RESPIRATORY PROBLEMS SECONDARY TO INCIDENT INVOLVING BURNS.

    Description of Event or Problem · 1

    THE MEDWATCH FORM ALLEGES THE CONSUMER WAS BURNED ON HIS HEAD, FACE, AND ARMS AS A RESULT OF SMOKING WHILE USING A HOME OXYGEN CONCENTRATOR. THE CONSUMER ALLEGEDLY PASSED AWAY 4 DAYS LATER DUE TO RESPIRATORY PROBLEMS. SECONDARY TO THE ALLEGED INCIDENT INVOLVING THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE OXYGEN CONCENTRATORS 868.5440 CAW INVACARE RESPIRATORY PRODUCTS IRC5LX02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death