BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 1983572 · Received February 2, 2011

    Report

    Report Number
    1525712-2011-00036
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 2, 2011
    Manufacturer
    INVACARE
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS CONTACTED BY A DEALER REGARDING A USER ALLEGING A CONCENTRATOR CAUGHT ON FIRE AND DAMAGED THEIR RUG. PHOTOS WERE PROVIDED BY THE CONSUMER OF LINE MARKS TO THE RUG AND SOME OF THE SIDE OF A COUCH. THE MARKS APPEAR IN THE FORM OF A LINE SIMILAR TO THE SUPPLY TUBING THAT ATTACHES TO A CONCENTRATOR. NO DEVICE PHOTOS WERE PROVIDED BY THE CONSUMER. THERE WERE NO INJURIES INVOLVED IN THIS ALLEGED INCIDENT. NATURE OF COMPLAINT SUGGESTS AN EXTERNAL SOURCE FROM THE DEVICE. MALFUNCTION NOT CONFIRMED. DEVICE HAS BEEN IN SERVICE FOR 8 YEARS AND IS NO LONGER IN WARRANTY. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR A USER SMOKING MAY HAVE CAUSED OR CONTRIBUTED TO THIS ALLEGED INCIDENT. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CONCENTRATOR CAUGHT ON FIRE AND BURNED HIS RUG. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1