BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 22092252 · Received May 27, 2025

    Report

    Report Number
    1039215-2025-00001
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 27, 2025
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 13, 2025, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A DISTRIBUTOR IN GERMANY THAT A POTENTIAL INCIDENT INVOLVING ONE OF OUR CONCENTRATORS AND AN OPEN FLAME PROVIDED BY THE PATIENT OCCURRED AND THAT INCIDENT RESULTED IN A MINOR INJURY TO THE PATIENT. ACCORDING TO THE DISTRIBUTOR THE PATIENT HELD AN OPEN FLAME TO THE END OF THE OXYGEN TUBING. THE PATIENT SUFFERED FIRST DEGREE BURNS TO BOTH HANDS AND WAS RELEASED AFTER TREATMENT. THE DISTRIBUTOR INCLUDED A STATEMENT FROM THE NURSE/CARETAKER SAYING THE USER "HELD AN OPEN FLAME TO THE OXYGEN TUBE AND WHEN ASKED WHY, THEY DIDN'T KNOW WHY THEY DID IT". PHOTOS PROVIDED BY THE DISTRIBUTOR SUPPORTED THE CARETAKER'S CLAIM AS THERE WAS NO DAMAGE TO THE DEVICE ITSELF, THEY ONLY NEEDED TO REPLACE THE PATIENT OXYGEN TUBING. ADDITIONALLY, ALL COMPONENTS ON THE INSIDE O FHT EDEVICE, INCLUDING ELECTRICAL COMPONENTS, ARE IN ACCEPTABLE CONDITIONS AND FUNCTION CORRECTLY. BASED ON THE PHOTOS AND STATEMENTS, ALONG WITH THE DISTRIBUTOR'S INVESTIGATION, IT IS DETERMINED THAT THE INCIDENT WAS NOT CAUSED BY THE DEVICE, BUT RATHER THE END USER OF THE DEVICE INTRODUCING AN OPEN FLAME TO THE OXYGEN TUBING. THE NUVO LITE INSTRUCTIONS FOR USE (IFU) CLEARLY STATES THAT OXYGEN PROMOTES RAPID BURNING AND STRICTLY PROHIBITS SMOKING OR THE PRESENSE OF OPEN FLAMES NEAR THE DEVICE OR ITS ACCESSORIES. NIDEK MEDICAL HAS DETERMINED THAT THE ROOT CAUSE OF THIS INCIDENT WAS USER NON-COMPLIANCE WITH THESE INSTRUCTIONS AND WARNINGS.

    Description of Event or Problem · 0

    ON MAY 13, 2025, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A DISTRIBUTOR IN GERMANY THAT A POTENTIAL INCIDENT INVOLVING ONE OF OUR CONCENTRATORS AND AN OPEN FLAME PROVIDED BY THE PATIENT OCCURRED AND THAT INCIDENT RESULTED IN A MINOR INJURY TO THE PATIENT. ACCORDING TO THE DISTRIBUTOR THE PATIENT HELD AN OPEN FLAME TO THE END OF THE OXYGEN TUBING. THE PATIENT SUFFERED FIRST DEGREE BURNS TO BOTH HANDS AND WAS RELEASED AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329893 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 925 42127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization