BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK 5 NUVO

    MDR report key: 3203699 · Received June 25, 2013

    Report

    Report Number
    1039215-2013-00002
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 25, 2013
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    "ON (B)(6) 2013, AT 04:00 AND WHILE I WAS ASLEEP, WITH MY WIFE THE CONCENTRATOR STARTED TO EMIT SMOKE AND FUMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286999 MARK 5 NUVO GENERATOR, OXYGEN PORTABLE CAW NIDEK MEDICAL PRODUCTS, INC. 905-003Q

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization