BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR SEP

    MDR report key: 395704 · Received May 13, 2002

    Report

    Report Number
    MW1025078
    Event Type
    Injury
    Date Received
    May 13, 2002
    Date of Event
    May 4, 2002
    Report Date
    May 13, 2002
    Manufacturer
    AIR SEP CORP
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT ISSUE, NOT DEVICE ISSUE. PT WAS SMOKING WHILE ON O2 CONCENTRATOR AT 4 L/M. THE CANNULA IGNITED AND PT RECEIVED BURNING TO FACIAL AREA. PT REPORTED TO HOSP FOR TREATMENT AND WAS KEPT OVERNIGHT FOR OBSERVATION FOR FAMILY MEMBER'S DIAGNOSIS OF CHRONIC AIRWAY OBSTRUCTION. IN HOUSE INVESTIGATION SHOWS THAT THE PT AND NEXT OF KIN WERE REPEATEDLY INSTRUCTED ON O2 SAFETY, NO SMOKING WHILE ON O2. PT REMARKED TO CO INVESTIGATING INDIVIDUAL, "THAT THEY KNEW BETTER" AND "IT WAS THEIR FAULT". PT WAS RE-INSTRUCTED ON OXYGEN SAFETY, ALONG WITH NEXT OF KIN. CONCLUSION: PT ISSUE NOT A DEVICE ISSUE. CO PLAN: RE-EVALUATE PT X 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SEP OXYGEN CONCENTRATOR CAW AIR SEP CORP NEW LIFE *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization