BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 1627278 · Received March 5, 2010

    Report

    Report Number
    1039215-2010-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 5, 2010
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K040892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS IN THE PROCESS OF BEING RETURNED FROM THE (B)(6).

    Description of Event or Problem · 1

    INTERNAL FIRE IN DEVICE THAT MELTED THROUGH THE CASING OF OXYGEN CONCENTRATOR. SMOKE FILLED THE ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA