BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

    MDR report key: 2043706 · Received March 29, 2011

    Report

    Report Number
    1525712-2011-00144
    Event Type
    Other
    Date Received
    March 29, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 29, 2011
    Manufacturer
    INVACARE
    Product Code
    CCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THE COMPRESSOR WEARS IN. DEVICE IS THERMALLY PROTECTED. MANUFACTURER IS ATTEMPTING TO OBTAIN THE PRODUCT FOR INSPECTION. FILING SOLELY ON THE ALLEGATION OF A BURNING SMELL, MALFUNCTION IS NOT CONFIRMED.

    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 THE COMPRESSOR WEARS IN. DEVICE IS THERMALLY PROTECTED. MANUFACTURER IS ATTEMPTING TO OBTAIN THE PRODUCT FOR INSPECTION. FILING SOLELY ON THE ALLEGATION OF A BURNING SMELL, MALFUNCTION IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE UNIT HAD A BURNING SMELL WHEN THE DEALER PLUGGED IT IN FOR THE FIRST TIME. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT HAD A BURNING SMELL WHEN THE DEALER PLUGGED IT IN THE FIRST TIME. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYZER, GAS, OXYGEN, GASEOUS-PHASE 868.1720 CCL INVACARE IRC10LX02

    Patients

    Seq Age Sex Outcome Treatment
    1