BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15093227 · Received July 25, 2022

    Report

    Report Number
    3004972304-2022-00027
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    April 20, 2022
    Report Date
    September 1, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 DISPLAYING ALARM CODE AL-P48, INDICATING LOW O2 AND NO FLOW. ALL COMPONENTS INSIDE THE CASE (SIEVE BEDS, AND VALVES) WERE COATED IN DUST. SIEVE DUST WAS NOT OBSERVED BEING EXPELLED FROM THE OUTLET BARB, SO IT CANNOT BE DETERMINED IF SIEVE DUST WAS REACHING THE PATIENT. THE QUANTITY OF DUST ON AND AROUND THE CIRCUIT BOARD MAY HAVE CAUSED DAMAGE TO STOP THE VALVES FROM FUNCTIONING.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED A MEDWATCH REPORT FROM THE FDA REPORTING THE FOLLOWING INCIDENT: THE CAIRE COMPANION 5 OXYGEN CONCENTRATOR MALFUNCTIONED, EXPELLING WHITE POWDER. ADDITIONAL INFORMATION WAS OBTAINED FROM MEMORIAL HERMANN: THE PATIENT'S DAUGHTER CALLED THE DME BECAUSE AN ALARM WENT OFF ON THE COMPANION 5. A YELLOW LIGHT AND DUST WENT ALL OVER THE ROOM OF THE HOME. THE EVENT OCCURRED ON (B)(6) 2022. THE DME STATED THERE WERE NO ADVERSE RELATED INJURIES. THE DME SUPPLIED THE PATIENT A NEW UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86458 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male