BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE COMFORT

    MDR report key: 17252594 · Received July 3, 2023

    Report

    Report Number
    3004972304-2023-00012
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 3, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. CAIRE INC. TECHNICAL SERVICE IS ATTEMPTING TO RETRIEVE THE DEVICE FOR TESTING AT THE COMPANY'S BALL GROUND, GA, USA FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE PATIENT'S DAUGHTER: MY FATHER IS SUFFERING FROM COPD AND HEART FAILURE. IN ORDER TO SUPPORT HIS OXYGENATION, WE PURCHASED THE FREESTYLE COMFORT FROM YOUR DISTRIBUTOR. YET, MY FATHER HAS BEEN SUFFERING FROM POOR OXYGENATION AT LEAST TWICE DURING THIS MAY. I AM DISAPPOINTED WITH THE PRODUCT QUALITY AND LOCAL SUPPLIER. I MAY GO FOR REGULATION PROCEDURE LATER THIS WEEK AND RISE THE PATIENT SAFETY ISSUE TO THE FDA. IF CAIRE AND THE LOCAL DISTRIBUTOR FEEDBACK ME WITH UNACCEPTABLE CONDITION. I UNDERSTOOD THE MY FATHER DISEASE PROGRESS, BUT I CANNOT ACCEPT MY FATHER TO BE PLACED IN HIGH RISK SITUATION DUE TO YOUR MACHINE. IT SHOWS SYSTEM ERROR NEITHER NO FLOW FROM MACHINE. FOR YOUR INFORMATION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20351 FREESTYLE COMFORT CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS200-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other