BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 17152198 · Received June 19, 2023

    Report

    Report Number
    1039215-2023-00001
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 16, 2023
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE REPORTING THIS OUT OF AN ABUNDANCE OF CAUTION. RECEIVED NOTIFICATION THAT PATIENT'S CAREGIVER BELIEVED DEVICE CAUSED SMOKE DETECTOR TO ALARM, BUT THAT NO PATIENT HARM OR ENVIRONMENTAL DAMAGE OCCURRED. SINCE DEVICE WAS LOCATED IN GERMANY, IT WAS SENT TO OUR AUTHORIZED SERVICE CENTER IN GREECE. THEIR INVESTIGATION REPORTED AS FOLLOWS: 'THE NUVO LITE DEVICE, SN (B)(6) HAS 9,307 HOURS. AFTER CONDUCTING ALL THE REQUIRED TESTS AND CHECKS ON THE DEVICE, WE FOUND THAT ALL THE FUNCTIONS OF THE DEVICE EITHER EXCEEDED OR MET UP TO THE REQUIRED SPECIFICATIONS AFTER RUNNING FOR 48 HOURS WITH NO PROBLEMS. THERE IS NO BURNT MATERIAL ANYWHERE. THERE IS ALSO NOT A TRACE OF SMOKE. IT IS EXCLUDED THAT THE SMOKE IN THE PATIENT'S ROOM CAME FROM THE DEVICE. HOWEVER, THE INSIDE OF THE DEVICE IS COVERED IN A THICK LAYER OF DUST AND FILTERS ARE VERY DIRTY.' AS THERE WAS NO VISUAL OR PHYSICAL EVIDENCE OF THERMAL DAMAGE, WE AS THE MANUFACTURER CONCLUDE THAT THE "SMOKING FROM THE VENTS" WAS MOST LIKELY DUST BEING EXHAUSTED FROM THE VENTS.

    Description of Event or Problem · 0

    INCIDENT DESCRIPTION PER DISTRIBUTOR "THE FATHER REPORTED TODAY THAT THE CONCENTRATOR WAS SMOKING FROM THE VENTS AT APPROXIMATELY 2 AM TONIGHT, CAUSING THE SMOKE DETECTOR IN THE PATIENT'S ROOM TO ALARM. THE CONCENTRATOR DID NOT SOUND AN ALARM. NO HARM WAS DONE TO THE PATIENT'S HEALTH.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814833 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 925 34932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown