BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE 5

    MDR report key: 15529030 · Received October 3, 2022

    Report

    Report Number
    3004972304-2022-00036
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 3, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE UNIT WILL NOT BE RETURNED FOR AN EVALUATION. THE PATIENT WAS SMOKING WHILE USING THE CONCENTRATOR. THE USER MANUAL CONTAINS WARNINGS TO NOT SMOKE WHILE USING THE DEVICE.

    Description of Event or Problem · 0

    ON SEPTEMBER 15, 2022, CAIRE WAS NOTIFIED OF THE BELOW INCIDENT BY ALEHOS: THE PATIENT SMOKED WITH THE CANNULA DIRECTLY CONNECTED TO THE CONCENTRATOR. THE PATIENT BURNED HIS NOSTRILS. THE CANNULA CAUGHT FIRE, BUT IT DID NOT AFFECT THE CONCENTRATOR. THE PATIENT HAS THE CORRECT INSTRUCTIONS FOR USE. THERE IS NO ADDITIONAL INFORMATION ABOUT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647449 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other