BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 5

    MDR report key: 15725305 · Received November 4, 2022

    Report

    Report Number
    3004972304-2022-00039
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 4, 2022
    Report Date
    December 15, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE DEVICE HAS BEEN RETURNED TO CAIRE 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 DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE COMPANION 5 UNIT WAS RECEIVED BY ENGINEERING AND NO EXTERNAL DAMAGE WAS FOUND. THE UNIT WAS TESTED FOR OUTLET PURITY, AT ALL SET POINTS THE OUTLET PURITY MAINTAINED ABOVE THE MINIMUM ALLOWED 87% O2. THE UNIT WAS TESTED FOR OUTLET FLOW RATES, AT ALL SETPOINTS THE OUTLET FLOW RATE WAS WITHIN THE SPECIFIED 10% OR 200ML WHICHEVER IS GREATER. THE UNIT WAS OPENED, AND NO INTERNAL DAMAGE WAS OBSERVED. THE COMPANION 5 UNIT PASSED ALL TESTING WITH NO ISSUE FOUND.

    Description of Event or Problem · 0

    ON OCTOBER 4, 2022, CAIRE RECEIVED A NOTIFICATION FROM REOX MEDICAL SERVICES OF THE BELOW INCIDENT: REOX RECEIVED A COMPANION 5 UNIT BACK FROM A CUSTOMER STATING THAT "PATIENT SAID MACHINE WAS CAUSING HER TO GET SICK." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509827 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown