BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE 5

    MDR report key: 12449086 · Received September 9, 2021

    Report

    Report Number
    3004972304-2021-00022
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 9, 2021
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS STILL BEING USED BY THE PATIENT, AND THE PATIENT WILL NOT RETURN THE DEVICE TO CAIRE FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CAIRE WAS NOTIFIED BY AIR LIQUIDE HEALTHCARE BENELUX ON (B)(6) 2021 OF A SERIOUS INCIDENT. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 DUE TO OXYGEN INTOXICATION. THERE HAS NOT BEEN ANY NOTIFICATION OF A DEVICE MALFUNCTION. THE PATIENT'S DAUGHTER CLEARLY INDICATED THAT SHE SUSPECTS WRONG USAGE OF THE DEVICE BY HER MOTHER, AS SHE WOULD INCREASE THE FLOWRATE HERSELF WITHOUT PERMISSION FROM HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346360 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization