BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 11793906 · Received May 7, 2021

    Report

    Report Number
    1039215-2021-00001
    Event Type
    Death
    Date Received
    May 7, 2021
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE. A PHOTOGRAPH FROM THE SCENE WAS PROVIDED AND SUGGESTED THAT SMOKING OCCURRED IN THE PATIENT'S HOME. PRODUCT LABELING STATES "THIS DEVICE SUPPLIES HIGHLY CONCENTRATED OXYGEN ENRICHED PRODUCT GAS THAT PROMOTES RAPID BURNING. DO NOT ALLOW SMOKING OR OPEN FLAMES WITHIN THE SAME ROOM OF THIS DEVICE OR THE ADMINISTRATION ACCESSORY (CANNULA). FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE, PROPERTY DAMAGE, AND / OR CAUSE PHYSICAL INJURY OR DEATH." THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION AND SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DISTRIBUTOR IN GREECE RECEIVED NOTIFICATION OF A DEVICE THAT WAS INVOLVED IN A HOUSE FIRE. DEVICE HAS NOT BEEN RETURNED AS THERE IS AN OPEN FIRE INVESTIGATION. THERE WAS PROPERTY DAMAGE AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690533 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS, INC. 925 36194

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death