BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 22742804 · Received August 7, 2025

    Report

    Report Number
    1039215-2025-00002
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 7, 2025
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED TO NIDEK MEDICAL PRODUCTS ON JULY 28, 2025. DURING THE FUNCTIONAL CHECK OF THE DEVICE, THE UNIT MAINTAINED FUNCTIONALITY AND PURITY UNTIL THE COMPRESSOR OVERHEATED, TRIGGERING A SAFETY SHUTDOWN OF THE COMPRESSOR AND CAUSING THE UNIT TO ALARM BOTH VISUALLY AND AUDIBLY. THE DEVICE WAS ASSESSED AND IT WAS FOUND THAT THE INTERNAL COOLING FAN WAS NOT OPERATING. WITHIN THE TIME IT TOOK THE COMPRESSOR TO SHUTDOWN AND THE UNIT TO BEGIN ALARMING, NO SMOKE WAS OBSERVED AND THERE WAS NO EVIDENCE ANY THERMAL OR SMOKE DAMAGE TO THE UNIT.

    Description of Event or Problem · 0

    ON JULY 18, 2025, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A DISTRIBUTOR IN SINGAPORE THAT A DEVICE EXPERIENCED OVERHEATING AND HAD SMOKE COMING FROM THE MACHINE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO INJURIES OR HEALTH EFFECTS TO THE PATIENT, NOR WAS THERE HARM TO THE PROPERTY OR ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410833 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 920 45545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown