BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3004005 · Received October 28, 2008

    Report

    Report Number
    1525712-2008-00037
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 22, 2008
    Manufacturer
    INVACARE
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER IS A KNOWN SMOKER. USER DID STATE HIS GIRLFRIEND HAD GIVEN HIM 4 CIGARETTES BEFORE SHE LEFT FOR WORK PRIOR TO THIS REPORTED INCIDENT. MANUFACTURER'S DEVICE WAS LOCATED BY A DOOR AND CONSUMER REPORTEDLY WAS IN THEIR BED. WHILE IN HIS BED HE FELT HEAT ON HIS ANKLE. USER REPORTEDLY SHUT THE UNIT OFF ACROSS THE ROOM. INFO INDICATES AN EXTERNAL SOURCE. DEVICE WAS NOT ON THE LOCATION OF THE ALLEGED FIRE. MDR FILED BASED ON INJURY TO FOOT.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CONCENTRATOR STARTED A HOUSE FIRE, CAUSING THE CONSUMER TO SUSTAIN SMOKE INHALATION AND BURNS. SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 BTI INVACARE IRC5LX02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R