BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 5

    MDR report key: 11637947 · Received April 8, 2021

    Report

    Report Number
    3004972304-2021-00006
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    February 22, 2021
    Report Date
    May 7, 2021
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EVALUATION. TESTING FOUND THAT THE COMPANION 5 CONCENTRATOR'S HIGH TEMPERATURE AND THE STRANGE SMELL REPORTED BY THE USER WAS CAUSED BY A NONFUNCTIONING COOLING FAN. FUNCTIONAL TESTING FOUND THAT THE CONCENTRATOR'S COOLING FAN APPEARS UNDAMAGED, BUT IT FAILS TO OPERATE WHEN CONNECTED TO POWER. THE FAN'S FAILURE TO OPERATE WOULD RESULT IN THE LOSS OF COOLING TO THE UNIT'S INTERNAL COMPONENTS AND WOULD RESULT IN A HIGH SURFACE TEMPERATURE AND CAN CAUSE A STRANGE SMELL TO EMANATE FROM THE UNIT AS ITS COMPONENTS HEAT UP BEYOND THEIR NORMAL OPERATING CONDITIONS. BASED ON THE UNIT'S DATE OF MANUFACTURE (03/10/2015) AND THE DATE OF SALE (2015), THE CONCENTRATOR HAS REACHED THE MINIMUM EXPECTED SERVICE LIFE OF FIVE YEARS STATED IN THE COMPANION 5 USER MANUAL (PN 15062781) AND THEREFORE IT IS LIKELY THAT THE FAN FAILED DUE TO WEAR AND TEAR CAUSED BY NORMAL OPERATION. PROPER USE OF THE UNIT AND ROUTINE MAINTENANCE ARE RECOMMENDED TO MITIGATE AND IDENTIFY PART FAILURES SUCH AS THE ONE EXPERIENCED BY THE CONCENTRATOR IN QUESTION. THE NONFUNCTIONING FAN WAS REMOVED FROM THE CONCENTRATOR AND A REPLACEMENT FAN WAS INSTALLED FOR THE PURPOSE OF CONDUCTING FUNCTIONAL TESTS. THE FUNCTIONAL TESTS SHOWED THAT THE UNIT OPERATED NORMALLY, AND WITHOUT ALARMS. THE HIGH TEMPERATURE CONDITIONS OR ABNORMAL SMELLS REPORTED BY THE USER WERE NOT DETECTED WITH THE REPLACEMENT COOLING FAN INSTALLED. ADDITIONALLY, NO DAMAGE TO THE UNIT WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY ADDITIONAL INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE FOLLOWING: I HAD PURCHASED A CAIRE COMPANION 5 OXYGEN CONCENTRATOR WHICH IS CURRENTLY OUT OF WARRANTY. FOR SEVERAL MONTHS I HAVE HAD WORSENING HEADACHES, INCLUDING MIGRAINE HEADACHES, AND AN INCREASE IN MENTAL FOGGINESS AND MEMORY DIFFICULTIES. I WAS CONCERNED THAT MY MEDICAL ISSUES MAY HAVE BEEN CAUSED BY MY OXYGEN CONCENTRATOR AS IT FELT QUITE HOT NEAR THE HANDLE AND SMELLED A LITTLE FUNNY. I CALLED A WHILE BACK AND WAS TOLD AS LONG AS THERE WERE NO WARNING LIGHTS, THERE WERE NOT, I SHOULD NOT WORRY ABOUT THE OXYGEN CONCENTRATOR BEING THE CAUSE OF MY PROBLEMS. I WAS TOLD IF THE COMPANION 5 WERE HAVING PROBLEMS THERE WOULD BE WARNING LIGHTS AND IF THE CONCENTRATOR WAS GETTING TOO HOT THERMAL PROTECTION WOULD AUTOMATICALLY SHUT IT OFF. MEDICAL ISSUES DETERIORATING, I TOOK IT TO A REPAIR FACILITY YESTERDAY AND THEY OPENED THE CASE AND TOLD ME THE FAN WAS NOT WORKING AND THE OVERHEATING HAD MELTED THE PLASTIC CAUSING TOXIC FUMES. THE UNIT WAS PURCHASED BY THE END USER IN 2015 AND HAS 16,000 HOURS. THE UNIT TURNS ON, AND IS USED OVERNIGHT. THE UNIT DOESN'T SHOW WARNING LIGHTS OR ERROR CODES, BUT STARTED GETTING HOT ON THE TOP AND EMITTING SMELLS FROM INSIDE THE UNIT. THE END USER TOOK THE UNIT TO A REPAIR PROVIDER ON FEB. 22 OR 23. THE REPAIR PROVIDER INDICATED THAT SOME INTERNAL COMPONENTS HAD MELTED, AND DIAGNOSED IT AS A BAD FAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532222 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other