BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2031894 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00127
    Event Type
    Other
    Date Received
    March 22, 2011
    Report Date
    May 11, 2012
    Manufacturer
    INVACARE
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. DEVICE WAS NEW. NATURE OF COMPLAINT SUGGESTS A NEW PRODUCT AND THE NEW COMPRESSOR WILL HAVE A SLIGHT ODOR AS IT WEARS IN. THIS ODOR IS NORMAL AND WILL DISSIPATE AS COMPRESSOR WEARS IN. DEVICE IS THERMALLY PROTECTED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. FILING SOLELY ON THE ALLEGATION OF A BURNING SMELL, MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. DEVICE WAS NEW. NATURE OF COMPLAINT SUGGESTS A NEW PRODUCT AND THE NEW COMPRESSOR WILL HAVE A SLIGHT ODOR AS IT WEARS IN. THIS ODOR IS NORMAL AND WILL DISSIPATE AS COMPRESSOR WEARS IN. DEVICE IS THERMALLY PROTECTED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. FILING SOLELY ON THE ALLEGATION OF A BURNING SMELL, MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE DEALER ALLEGES WHEN HE TOOK THE UNIT OUT OF THE BOX AND PLUGGED IT IN, IT SMELLED LIKE SOMETHING WAS BURNING.

    Description of Event or Problem · 1

    THE DEALER ALLEGES WHEN HE TOOK THE UNIT OUT OF THE BOX AND PLUGGED IT IN, IT SMELLED LIKE SOMETHING WAS BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1