BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2170548 · Received July 21, 2011

    Report

    Report Number
    1525712-2011-00358
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 14, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    BYJ
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY STARTED TO SMOKE AND STOPPED WORKING WHILE THE CONSUMER WAS USING THE UNIT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY STARTED TO SMOKE AND STOPPED WORKING WHILE THE CONSUMER WAS USING THE UNIT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 BYJ INVACARE FLORIDA OPERATIONS TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1