BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 16077802 · Received December 30, 2022

    Report

    Report Number
    3004972304-2022-00050
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Report Date
    April 18, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 UNIT 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 COMPANION 5 UNIT WAS NOT ALARMING AT ANY TIME, AND FUNCTIONAL TESTING DETERMINED THE UNIT TO BE OPERATING NORMALLY. THE OBSTRUCTION IN THE GROSS PARTICLE FILTER MAY RESTRICT FLOW TO THE COMPRESSOR, CAUSING CUP SEAL WEAR AND DISCOLORATION TO INTERNAL COMPONENTS. THE GROSS PARTICLE FILTER WAS ADVERSELY IMPACTED BY FACTORS IN THE OPERATING ENVIRONMENT COMBINED WITH IMPROPER ROUTINE MAINTENANCE PER THE OPERATING MANUAL. THE BLACK COATING ON THE EXTERNAL CASE COMPONENTS WAS NOT DETERMINED TO BE RELATED TO FIRE DAMAGE, AS NO INTERNAL COMPONENTS WERE MELTED OR SHOWED ANY SIGNS OF DAMAGE. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 0

    CAIRE DISCOVERED THE UNIT IN REPAIRS. UPON EVALUATION, THE UNIT WAS SHOWN TO HAVE FIRE DAMAGE. NO INJURIES WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354583 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown