BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE COMFORT

    MDR report key: 15874378 · Received November 28, 2022

    Report

    Report Number
    3004972304-2022-00046
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 28, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    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 ENGINEERING REVIEW CONCLUDED THE FOLLOWING: THE UNIT WAS RECEIVED WITHOUT THE ACCESSORIES NOTED IN THE ADVERSE EVENT. THE UNIT RAN SUCCESSFULLY ON BATTERY POWER AND VIA POWER SUPPLY. THE UNIT WAS TESTED ON SETTING 5 FOR GREATER THAN 30 MINUTES, BOTH ON POWER SUPPLY AND ON 12V CAR CHARGER. AFTER 30 MINUTES OF RUNTIME ON A CAR CHARGER, THE CASE TEMPERATURE WAS DOCUMENTED AT 43.33 DEGREES CELSIUS. RUNNING THE UNIT ON AN ENGINEERING-PROVIDED POWER SUPPLY OR CAR CHARGER GENERATED NORMAL HEAT LEVELS IN BOTH THE UNIT AND CHARGING ACCESSORIES. ENGINEERING WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH ENGINEERING-PROVIDED ACCESSORIES AND THE UNIT PERFORMANCE WAS WITHIN SPECIFICATIONS. NO FURTHER TESTING IS REQUIRED.

    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 CORRESPONDING WITH BOTH THE PATIENT AND THE PROVIDER COMPANY TO HAVE THE UNIT RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CAIRE RECEIVED A VOLUNTARY MEDWATCH REPORT (MDR REPORT # MW5112942). REOCCURRING ISSUE WITH CONSTANT BLOWING OF FUSES BOTH IN CAR AND IN UNITS POWER CORD. CAIRE FREESTYLE COMFORT PORTABLE OXYGEN CONCENTRATOR. WE HAVE REPLACED FUSES IN MY 2017 DODGE 4X ON THE DATE ABOVE THERE WAS A AUDIBLE POP AND IT BLEW OUT A GOOD PORTION OF MY VEHICLES ELECTRICAL DASH LIGHTING. CURRENTLY AWAITING TO GET IT IN FOR SERVICE. THIS IS A NEW UNIT AND WAS REPLACED BY MY SUPPLIER MULTIPLE TIMES FOR SIMILAR ISSUES. HOME POWER BRICK HEATS UP TO TEMPERATURE THAT WILL ALMOST BURN YOU IF YOU PICK IT UP. I AM AFRAID THAT IT WILL START MY HOME OR VEHICLE, OR WORSE ME, ON FIRE. IT SUPPLIES OXYGEN AND SHOULD NOT BE FUNCTIONING LIKE THIS. MY MEDICAL SUPPLIER IS OF NO HELP AND REACHING OUT TO MANUFACTURER HAS NOT BEEN PRODUCTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083938 FREESTYLE COMFORT CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS200-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown