BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE 5

    MDR report key: 12102910 · Received July 1, 2021

    Report

    Report Number
    3004972304-2021-00017
    Event Type
    Injury
    Date Received
    July 1, 2021
    Report Date
    September 27, 2021
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    501

    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 DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE CUSTOMER STATED THAT THE VISIONAIRE STATIONARY OXYGEN CONCENTRATOR UNIT CAUSED THE PATIENT TO SUFFER A SEVERE NOSEBLEED, HOWEVER THIS IS UNLIKELY TO HAVE OCCURRED AS A RESULT OF A MALFUNCTION OF THE OXYGEN CONCENTRATOR TEST UNIT. WITH THE EXCEPTION OF LOW OUTPUT OXYGEN PURITY AT 5 LPM, THIS EVALUATION FOUND THAT THE VISIONAIRE TEST UNIT IS UNDAMAGED, FUNCTIONS NORMALLY, AND THAT IT MEETS ITS FUNCTIONAL SPECIFICATIONS. EXTERNAL FACTORS, UNRELATED TO THE FUNCTION OF THE CONCENTRATOR, COULD HAVE LED TO THE NOSEBLEEDS THAT THE PATIENT EXPERIENCED.

    Additional Manufacturer Narrative · 1

    CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE USE OF A VISIONAIRE CONCENTRATOR, THE PATIENT SUFFERED FROM A NOSEBLEED THAT WAS SO SERIOUS, THE PATIENT DECIDED TO STOP HIS OXYGEN THERAPY FOR APPROXIMATELY TWO WEEKS. THREE WEEKS LATER, THE PATIENT IS DOING BETTER AND HAS RESTARTED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000707 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other