BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15263083 · Received August 20, 2022

    Report

    Report Number
    3004972304-2022-00031
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Report Date
    August 19, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON JULY 22, 2022, CAIRE RECEIVED A REPORT FROM ATLANTIC HEALTHCARE OF THE BELOW INCIDENT: IT WAS REPORTED THAT THE COMPANION 5 SIEVE BED BLEW UP IN THE PATIENT'S HOUSE, AND THE PATIENT HAD TO GET AN OUTSIDE COMPANY TO CLEAN UP THE MESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302930 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown