BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15805262 · Received November 16, 2022

    Report

    Report Number
    3004972304-2022-00041
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Report Date
    December 30, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 WAS RETURNED TO CAIRE FOR AN INVESTIGATION. 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 UNIT 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 RMA FOR REPAIRS. THE TECHNICIAN EVALUATED THE UNIT AND FOUND SIEVE DUST COMING THROUGH THE O2 OUTLET. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349902 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown