BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE COMFORT

    MDR report key: 11793777 · Received May 7, 2021

    Report

    Report Number
    3004972304-2021-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    July 21, 2021
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, NEITHERTHIS 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'S BALL GROUND FACILITY FOR AN EVALUATION. THE EVALUATION OF THE FREESTYLE COMFORT PORTABLE OXYGEN CONCENTRATOR INVOLVED IN THE ADVERSE EVENT FOUND THAT THE LIKELY SOURCE OF THE WHITE SMOKE DESCRIBED COMING OUT OF THE UNIT WAS THE PLASTIC COMPRESSOR INTAKE TUBE RETAINER (PN MI395-1). THE COMPRESSOR INTAKE TUBE RETAINER WAS FOUND TO HAVE PARTIALLY MELTED AND FUSED ITSELF TO THE COMPRESSOR CASE. THIS SUGGESTS THAT THE OXYGEN CONCENTRATOR EXPERIENCED A HIGH TEMPERATURE EVENT IN WHICH TEMPERATURES ACROSS THE CONCENTRATOR'S COMPRESSOR REACHED ABOVE 110°C, THE SOFTENING TEMPERATURE OF THE POLYCARBONATE AND ABS PLASTIC MIX USED FOR THE CONSTRUCTION OF THE COMPRESSOR INTAKE TUBE RETAINER, FOR A PROLONGED PERIOD OF TIME. MULTIPLE OPERATIONAL TESTS AND ENVIRONMENTAL TESTS WHICH MONITORED THE OXYGEN CONCENTRATOR'S CASE TEMPERATURE AND THE TEMPERATURES ACROSS MULTIPLE POINTS ALONG ITS COMPRESSOR COULD NOT REPLICATE THE HIGH TEMPERATURE CONDITION NECESSARY TO SOFTEN OR MELT THE PLASTIC OF THE COMPRESSOR INTAKE TUBE RETAINER. THROUGHOUT TESTING, THE OXYGEN CONCENTRATOR OPERATED AS INTENDED, WITHOUT EXHIBITING ANY ABNORMAL BEHAVIORS OR ALARMS, AND BASIC FUNCTIONAL TESTING FOUND THAT IT MEETS ITS FUNCTIONAL SPECIFICATIONS. ADDITIONALLY, ALL DAMAGE INCURRED BY THE UNIT BY THE ADVERSE EVENT, WAS CONTAINED TO THE COMPRESSOR INTAKE TUBE RETAINER AND NO INJURIES WERE REPORTED AS A RESULT. ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE INCIDENT: THE PATIENT REPORTED USING THE UNIT IN A LOW TEMPERATURE ENVIRONMENT (-20C) FIRST, AND THEN INTO A WARMER TEMPERATURE ENVIRONMENT (15C). THE OPERATING TEMPERATURE OF THE DEVICE AS DETAILED IN THE USER MANUAL IS 5C TO 40C.

    Additional Manufacturer Narrative · 1

    "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 BALL GROUND FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE UNIT WAS IDENTIFIED IN CAIRE (B)(6) REPAIRS. THE CUSTOMER REPORTED THAT WHITE SMOKE WAS PRODUCED WHEN THE UNIT WORKED FROM THE PLACE OF TEMPERATURE OF MINUS 20 DEGREES TO AMBIENT 15 DEGREES, AS WELL AS IT HAD AN UNNORMAL SMALL IN ITS OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685941 FREESTYLE COMFORT OXYGEN CONCENTRATOR, PORTABLE CAW CAIRE INC. AS200-109

    Patients

    Seq Age Sex Outcome Treatment
    1