BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE 5

    MDR report key: 16469585 · Received March 2, 2023

    Report

    Report Number
    3004972304-2023-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    December 29, 2022
    Report Date
    February 10, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    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. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    PATIENT WAS USING DEVICE BUT NO 02 WAS COMING OUT; ALARM DIDN'T WORK. ISSUE WAS NOTICED WHEN SERVICE COMPANY CAME TO CHECK THE MEDICAL DEVICE. O2 SETTING WAS AT 2L/MN. PATIENT DIDN'T NOTICE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825751 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male