BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE 3

    MDR report key: 10233935 · Received July 6, 2020

    Report

    Report Number
    3004972304-2018-00061
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    August 12, 2018
    Report Date
    October 25, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. DURING FURTHER INVESTIGATION, THE FOLLOWING WAS IDENTIFIED: MAXON MOTORS PERFORMED AN EXTENSIVE ROOT-CAUSE ANALYSIS AND FAILURE INVESTIGATION. MAXON DID NOT IDENTIFY ANY DESIGN ISSUES TO CAUSE THIS FAILURE MODE. MAXON FOCUSED ON FORCING MALFUNCTION BY ARTIFICIALLY DAMAGING COMPONENTS TO MIMIC IMPROPER HANDLING DURING INSTALLATION OR SERVICE IN THE FIELD. EVEN IN THE CASE OF A FORCED DAMAGE, THE BURNT PCB AREAS OBSERVED BY ALL TESTS HAVE BEEN LESS THAN BY THE RETURN SHIPMENTS. CONCENTRATED OXYGEN OR AIR FLOW MAY HAVE BEEN AN INFLUENCING FACTOR WHICH CAN INCREASE THE BURNING OR FLAMING EFFECT AS SEEN IN THE RETURNED UNITS. THERE HAVE NOT BEEN ANY SYSTEMIC ISSUES IDENTIFIED. WE WILL CONTINUE TO MONITOR COMPLAINTS.

    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. UNIT WAS RETURNED FOR AN EVALUATION. BASED ON THE DAMAGE FOUND IN THE UNIT, IT CAN BE CONCLUDED THAT THE INCIDENT STARTED INTERNALLY. IT CAN BE SEEN THAT THE INCIDENT STARTED FROM THE MOTOR CONTROL BOARD. THE INCIDENT HAPPENED LONG ENOUGH IN ORDER TO BURN THE FILTER AND CASING IN FRONT OF THE MOTOR CONTROL BOARD. THE MOTOR CONTROL BOARD FROM THE UNIT WAS COMPARED TO A NEW MOTOR CONTROL BOARD FOR RESISTANCE ACROSS THE PLANES. THE BOARD ON THE UNIT MEASURED 18.7 OHMS WHILE THE NEW BOARD MEASURED 359K OHMS. NO OTHER INTERNAL PARTS WERE DAMAGED DURING THE EVENT OTHER THAT THE FILTER AND A SMALL SECTION OF THE FRONT PLASTIC. FROM THESE OBSERVATIONS, THE INCIDENT STARTED FROM THE MOTOR CONTROL BOARD.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/25/2019, AND IS BEING RESUBMITTED ON 7/6/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. END USER WAS IN A HOTEL ROOM AND WAS USING THE MACHINE. SUDDENLY THE FREESTYLE STARTED SMOKING, NO FLAMES COMING OUT OF THE UNIT BUT A LOT OF SMOKE. END USER THEN WENT TO FLORIDA HOSPITAL RESP. & EQUIP. ON (B)(6) 2018 TO LET THEM KNOW OF THE SITUATION. ONCE THE COMPANY RECEIVED THE UNIT THEY LET CAIRE KNOW THEY HAD A BURNED UNIT.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 4/5/2019, AND IS BEING RESUBMITTED ON 7/6/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. END USER WAS IN A HOTEL ROOM AND WAS USING THE MACHINE. SUDDENLY THE FREESTYLE STARTED SMOKING, NO FLAMES COMING OUT OF THE UNIT BUT A LOT OF SMOKE. END USER THEN WENT TO (B)(6) HOSPITAL RESP. & EQUIP. ON (B)(6) 2018 TO LET THEM KNOW OF THE SITUATION. ONCE THE COMPANY RECEIVED THE UNIT THEY LET CAIRE KNOW THEY HAD A BURNED UNIT.

    Additional Manufacturer Narrative · 1

    UNIT IS BEING RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 9/12/2018, AND IS BEING RESUBMITTED ON 7/6/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. END USER WAS IN A HOTEL ROOM AND WAS USING THE MACHINE. SUDDENLY THE FREESTYLE STARTED SMOKING, NO FLAMES COMING OUT OF THE UNIT BUT A LOT OF SMOKE. END USER THEN WENT TO (B)(6) HOSPITAL RESP. & EQUIP. ON (B)(6) 2018 TO LET THEM KNOW OF THE SITUATION. ONCE THE COMPANY RECEIVED THE UNIT THEY LET CAIRE KNOW THEY HAD A BURNED UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699350 FREESTYLE 3 OXYGEN CONCENTRATOR, PORTABLE CAW CAIRE INC. AS095-101

    Patients

    Seq Age Sex Outcome Treatment
    1