BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15723973 · Received November 4, 2022

    Report

    Report Number
    3004972304-2022-00040
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Report Date
    December 15, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS RETURNED TO CAIRE AND EVALUATED. THE COMPANION 5 UNIT WAS DISPLAYING ALARM CODE AL-P08, INDICATING LOW O2. ALL COMPONENTS INSIDE THE CASE WERE COATED IN DUST. SIEVE DUST WAS OBSERVED BEING EXPELLED FROM THE OUTLET BARB. FOR THE SIEVE DUST TO BE EXPELLED FROM THE BARB, TWO FAULTS MUST HAVE OCCURRED ON THE UNIT. THESE FAULTS ARE SIEVE BED FAILURE AND OUTLET GAS FILTER. FAULT ORDER WAS INCONCLUSIVE, BUT THE UNIT WOULD ALARM FOR THE FAILURE OF THE SIEVE BED.

    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.

    Description of Event or Problem · 0

    THE UNIT WAS RETURNED TO CAIRE REPAIRS WITH OTHER UNITS. THE EVALUATION OF THE DUSTED UNITS DETERMINED THAT THIS UNIT HAD SIEVE DUST COMING THROUGH THE O2 OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783880 COMPANION 5 CONCENTRATOR, STATIONARY, OXYGEN CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown