BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE 3

    MDR report key: 9938358 · Received April 8, 2020

    Report

    Report Number
    3004972304-2020-00012
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    November 27, 2019
    Report Date
    June 2, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. BASED ON THE DAMAGE FOUND ON THE MOTOR CONTROLLER MODULE, IT CAN BE DETERMINED THAT THE CONCENTRATOR MALFUNCTION WAS CAUSED BY THE FAILURE OF ONE OF ITS BOARD MOUNTED COMPONENTS. MEASUREMENTS TAKEN WITH A MULTIMETER FOUND A SHORT-CIRCUIT ACROSS THE MAIN BOARD POWER. ADDITIONALLY, A HIGH AMOUNT OF DUST, HAIR, DEBRIS AND PARTICULATE WAS FOUND ON THE BOARD. IT IS LIKELY THAT FOREIGN MATERIAL CONTRIBUTED TO THE MALFUNCTION OF THIS CIRCUIT BOARD ASSEMBLY. BECAUSE THE CONCENTRATOR INVOLVED IN THE ADVERSE EVENT WAS NOT PROVIDED, NO FURTHER TESTING COULD BE CONDUCTED. NO INJURIES RESULTED FROM THE ADVERSE EVENT. THE MOTOR CONTROL BOARD SUPPLIER PERFORMED AN EXTENSIVE ROOT-CAUSE ANALYSIS AND FAILURE INVESTIGATION. THE SUPPLIER DID NOT IDENTIFY ANY DESIGN ISSUES TO CAUSE THIS FAILURE MODE. THE SUPPLIER 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.

    Description of Event or Problem · 1

    THE FREESTYLE 3 DEVICE WAS RETURNED TO NGK (B)(4) FOR REPAIR WITH THE COMPLAINT: "UNIT DOES NOT FLOW". A BURNT MOTOR CONTROL BOARD WAS OBSERVED DURING REPAIRS. THERE WAS NO INDICATION OF ANY INJURY TO OR INCIDENT INVOLVING A PATIENT. THE UNIT PASSED ALL REPAIR TESTING AND WAS RETURNED TO SERVICE. THE BOARD WAS RETURNED TO CAIRE FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402405 FREESTYLE 3 CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS095-103

    Patients

    Seq Age Sex Outcome Treatment
    1