BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2031913 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00131
    Event Type
    Other
    Date Received
    March 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 22, 2011
    Manufacturer
    INVACARE
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER ALLEGES A WHITE SUBSTANCE WAS IN THE ROOM WITH THE PT WHILE THE CONCENTRATOR IS RUNNING. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. USER ALLEGEDLY HAD GONE TO THEIR DR. CONCENTRATOR HAD BEEN IN SERVICE FOR NEARLY TWO YEARS, SERVICE AND MAINTENANCE HISTORY IS UNK. SOURCE OF ALLEGED WHITE SUBSTANCE IS UNK. IT IS ALSO NOT KNOWN IF DEVICE WAS FROM DEALER'S RENTAL STOCK. MDR FILED BASED ON ALLEGED MEDICAL INTERVENTION. MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER'S DAUGHTER WENT INTO HER MOTHER'S ROOM AROUND 5:00 AM AND ALLEGES THERE WAS A WHITE FILM IN THE AIR. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR