BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO 10

    MDR report key: 23199602 · Received October 2, 2025

    Report

    Report Number
    1039215-2025-00003
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 2, 2025
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K093308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED TO NIDEK MEDICAL PRODUCTS ON SEPTEMBER 15, 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 ONE OF THE THREE INTERNAL COOLING FANS 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 SEPTEMBER 11, 2025, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A DISTRIBUTOR IN (B)(6) 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
    2451157 MARK 5 NUVO 10 OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 595 45783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown