BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR SEP

    MDR report key: 139988 · Received December 18, 1997

    Report

    Report Number
    139988
    Event Type
    Injury
    Date Received
    December 18, 1997
    Date of Event
    July 27, 1997
    Report Date
    September 1, 1997
    Manufacturer
    AIR SEP CORP.
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ON HOME O2 3.5 LNC PER CONCENTRATOR. HOME (MOBILE HOME) BURNED/DESTROYED BY FIRE ON APPROX 7/27/97. PT HOSPITALIZED FEW DAYS FOR SMOKE INHALATION. TWO DAYS AFTER BEING D/C'D FOR HOSP STAY W/ DX OF COPD, PNEUMONIA, RESPIRATING ARREST. PT HAD HX OF SMOKING, UNKNOWN IF PT SMOKING AT TIME OF FIRE. FIRE MARSHALL STATED CAUSE OF FIRE LISTED AS UNDETERMINED. ORIGIN OF FIRE IN SAME ROOM AS CONCENTRATOR WAS. CONCENTRATOR NOT NOTED TO BE SOURCE OF IGNITION. PT REPORTS (PER HP) LYING ON COUCH W/O2 ON, HEARD A LOW EXPLOSION THEN NOTED FLAMES ALL AROUND HER AND IMMEDIATELY MOVED OUTSIDE THE HOME. WAS TRANSPORTED TO LOCAL HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SEP HOME O2 CONCENTRATOR CAW AIR SEP CORP. NEWLIFE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L