BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE 5

    MDR report key: 15262988 · Received August 20, 2022

    Report

    Report Number
    3004972304-2022-00030
    Event Type
    Injury
    Date Received
    August 20, 2022
    Date of Event
    July 7, 2022
    Report Date
    October 17, 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 VISIONAIRE USER MANUAL CONTAINS WARNINGS TO AVOID SMOKING OR OPEN FLAMES NEAR THE DEVICE WHILE IN USE. CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 VISIONAIRE USER MANUAL CONTAINS WARNINGS TO AVOID SMOKING OR OPEN FLAMES NEAR THE DEVICE WHILE IN USE. THE DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE UNIT WAS FUNCTIONING AS INTENDED. THE PATIENT WAS SMOKING WHILE USING THE UNIT. THE BLACK MARKINGS ON THE UNIT COULD BE FROM THE EVENT BUT IT IS NOT KNOWN. THE UNIT WAS WORKING PROPERLY AT ALL SETTINGS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED A NOTIFICATION OF THE BELOW INCIDENT FROM FRANCE OXYGENE: THE PATIENT WAS BURNT AT THE NOSE AND FACE DUE TO THE USE OF OXYGEN WHILE HE WAS SMOKING A CIGARETTE. THE PATIENT WENT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941029 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization