BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15528417 · Received October 3, 2022

    Report

    Report Number
    3004972304-2022-00035
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 9, 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
    FL, 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. CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. 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 HAD DUST COMING OUT OF THE VENTS AND OUTLET BARB. DUE TO THIS NO OXYGEN OR FLOW READINGS WERE TAKEN. UPON INTERNAL INSPECTION IT WAS FOUND TO BE EXTREMELY DUSTY AS ALL COMPONENTS WERE COVERED. 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. NO FURTHER INSPECTION OF COMPONENTS WAS TAKEN.

    Description of Event or Problem · 0

    ON SEPTEMBER 15, CAIRE WAS NOTIFIED OF THE BELOW INCIDENT FROM 1ST CLASS MEDICAL: A COMPANION 5 UNIT SUFFERED A SIEVE FAILURE THAT DISPERSED WHITE POWDER ALL OVER HER FLOOR. SHE TOLD HER PROVIDER THAT THIS INCIDENT THAT OCCURRED WOULD COST HER $150 TO CLEAN. SHE BELIEVES SHE MAY HAVE BEEN BREATHING IN THIS DUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186188 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female