BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 2845056 · Received October 24, 2012

    Report

    Report Number
    1039215-2012-00004
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    August 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT IS BEING RETURNED TO NIDEK MEDICAL PRODUCTS, INC. FOR INVESTIGATION/EVALUATION. AS OF THIS DATE, IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DESCRIPTION OF THE INCIDENT IS AS FOLLOWS: SERIAL NUMBER OF THE NUVO (B)(4). DATE OF THE INCIDENT: (B)(6) 2012. "THE DEVICE WAS USED AT NIGHT AT A PT'S HOME IN (B)(6). THE FLOWRATE WAS SET AT 3L/MIN. THE TEMPERATURE AT NIGHT WAS QUITE HIGH (AROUND 30 DEG. C) AND THE BEDROOM WAS VENTILATED (THE WINDOW WAS KEPT OPEN). THE NUVO WAS REPORTED TO HAVE IGNITED BY ITSELF AND THE FIRE STARTED SPREADING IN THE ROOM. BY CHANCE THERE WAS NO CONSEQUENCE FOR THE PT WHO COULD ALERT THE FIREMEN ON TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK 5 NUVO GENERATOR, OXYGEN PORTABLE CAW NIDEK MEDICAL PRODUCTS, INC. 500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK