BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 20419548 · Received October 10, 2024

    Report

    Report Number
    1039215-2024-00003
    Event Type
    Death
    Date Received
    October 10, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 10, 2024
    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 SEPTEMBER 19, 2024 NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A GERMAN DISTRIBUTOR CONCERNING A FIRE INVOLVING A NIDEK MEDICAL NUVO LITE OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(6). THE END USER OF THE DEVICE DIED IN THE FIRE. IN THEIR INITIAL REPORT, THE DISTRIBUTOR INDICATED THAT THE END USER WAS IN A FACILITY RECEIVING LONG-TERM CARE AND WAS CAUTIONED TO NOT SMOKE WHILE OPERATING THE DEVICE. ON SEPTEMBER 19, 2024 NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A GERMAN DISTRIBUTOR CONCERNING A FIRE INVOLVING A NIDEK MEDICAL NUVO LITE OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(6). THE END USER OF THE DEVICE DIED IN THE FIRE. IN THEIR INITIAL REPORT, THE DISTRIBUTOR INDICATED THAT THE END USER WAS IN A FACILITY RECEIVING LONG-TERM CARE AND WAS CAUTIONED TO NOT SMOKE WHILE OPERATING THE DEVICE. THE DISTRIBUTOR INCLUDED A STATEMENT FROM THE NURSE WHO WAS CARING FOR THE END USER. THE NURSE SAID, "THE PATIENT TOUCHED THE NASAL CANNULA WITH A LIT CIGARETTE AND THIS CAUSED THE DEVICE TO BURN BACK AND BE DAMAGED." PHOTOS PROVIDED BY THE DISTRIBUTOR SUPPORTED THE NURSE'S CLAIM. THE DEVICE ARRIVED AT THE MANUFACTURER'S FACILITY ON SEPTEMBER 30, 2024. THE FRONT HOUSING OF THE DEVICE IS THE ONLY NON-ACCESSORY COMPONENT OF THE DEVICE THAT SUSTAINED DAMAGE; ALL COMPONENTS ON THE INSIDE OF THE DEVICE, INCLUDING ELECTRICAL COMPONENTS, ARE IN ACCEPTABLE CONDITIONS AND FUNCTION CORRECTLY. BASED ON THE PHOTOS AND STATEMENTS PROVIDED, ALONG WITH THE MANUFACTURER'S INVESTIGATION, IT IS DETERMINED THAT THE FIRE ORIGINATED OUTSIDE THE DEVICE, CAUSED BY THE END USER OF THE DEVICE SMOKING WHILE USING THE DEVICE. THE NUVO LITE INSTRUCTIONS FOR USE (IFU) CLEARLY STATE THAT OXYGEN PROMOTES RAPID BURNING AND STRICTLY PROHIBIS SMOKING OR THE PRESENCE OF OPEN FLAMES NEAR THE DEVICE OR ITS ACCESSORIES. FURTHERMORE, THE IFU HIGHLIGHS THE RISKS ASSOCIATED WITH SMOKING WHILE USING THE CONCENTRATOR, CATEGORIZING IT AS A CONTRAINDICATION DUE TO THE INCREASED RISK OF FIRE. THE IFU ALSO DETAILS THE INCLUDSION OF SAFETY FEATURES SUCH AS A METAL FIRE BREAK AT THE OXYGEN OUTLET TO PREVENT FIRE FROM ENTERING THE DEVICE. 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 SEPTEMBER 19, 2024, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY A DISTRIBUTOR IN GERMANY THAT A POTENTIAL INCIDENT INVOLVING ONE OF OUR CONCENTRATORS AND A PATIENT SMOKING OCCURRED, AND THAT INCIDENT RESULTED IN THE PATIENT'S DEATH. ACCORDING TO THE DISTRIBUTOR, THE PATIENT HAD BEEN ON THERAPY SINCE (B)(6) 2024 AND HAD BEEN ADVISED IN THE PRESENCE OF THE CAREGIVER TO NOT USE THE DEVICE WHILE SMOKING. THEY FURTHER INCLUDED THAT ADDDITIONALLY ON (B)(6) 2024 THE DEVICE HAD BEEN EQUIPPED WITH A FIRESAFE FIRE PROTECTION VALVE AND HAD PROVIDED THE IFU TO THE PATIENT AND CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924721 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 925 43005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death