BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO 10

    MDR report key: 20196893 · Received September 11, 2024

    Report

    Report Number
    1039215-2024-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K093308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NIDEK MEDICAL PRODUCTS RECEIVED A REPORT FROM THE SON OF AN END USER OF THE NUVO 10 OXYGEN CONCENTRATOR. THE END USER WAS REPORTEDLY SMOKING WHILE USING THE DEVICE, WHICH LED TO A FIRE INVOLVING THE OXYGEN TUBING AND THE CONCENTRATOR ITSELF. ACCORDING TO THE DISTRIBUTOR'S INVESTIGATION, SUPPORTED BY PHOTOS AND AN INCIDENT REPORT, THE FIRE WAS MOST LIKELY CAUSED BY IGNITION OF THE OXYGEN TUBING DUE TO THE USER'S SMOKING. THE DEVICE WAS RETURNED TO NIDEK FOR FURTHER EVALUATION. UPON INSPECTION, IT WAS FOUND THAT THE EXTERNAL CABINET AND CONTROL PANEL HAD MELTED WHERE THE TUBING MADE CONTACT WITH THE DEVICE. HOWEVER, THE INTERNAL COMPONENTS, INCLUDING THE AIR COMPRESSOR, CAPACITOR, AND CIRCUIT BOARD, REMAINED INTACT AND OPERATIONAL. THE DAMAGE WAS CONSISTENT WITH EXTERNAL HEAT EXPOSURE RATHER THAN INTERNAL COMPONENT FAILURE, SUPPORTING THE CONCLUSION THAT THE FIRE ORIGINATED FROM THE OXYGEN TUBING, AS PER THE DISTRIBUTOR'S FINDINGS. THE NUVO 10 INSTRUCTIONS FOR USE (IFU) CLEARLY STATE THAT OXYGEN PROMOTES RAPID BURNING AND STRICTLY PROHIBIT SMOKING OR THE PRESENCE OF OPEN FLAMES NEAR THE DEVICE OR ITS ACCESSORIES. FURTHERMORE, THE IFU HIGHLIGHTS 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 INCLUSION 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 AUGUST 20, 2024, NIDEK MEDICAL PRODUCTS WAS CONTACTED BY THE SON OF AN END USER OF A NUVO 10 OXYGEN CONCENTRATOR. THE SON REPORTED THAT THE END USER, WHILE ON THE FRONT PORCH, HAD A NEIGHBOR WHO SMELLED BURNING RUBBER AND SUBSEQUENTLY DISCOVERED THE CONCENTRATOR INSIDE THE HOUSE ON FIRE. THEY UNPLUGGED THE UNIT FROM THE WALL AND THE FIRE SELF EXTINGUISHED. THERE WAS NO HARM TO THE END USER, BUT THERE WAS MINOR PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622287 MARK 5 NUVO 10 OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 595 40200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male