BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE COMFORT

    MDR report key: 13588298 · Received February 23, 2022

    Report

    Report Number
    3004972304-2022-00009
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Report Date
    May 23, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION AND IS ATTEMPTING TO GATHER MORE INFORMATION ABOUT THE INCIDENT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DEVICE WAS RETURNED TO CAIRE FOR AN INVESTIGATION. THE EVALUATION OF THE FREESTYLE COMFORT PORTABLE OXYGEN CONCENTRATOR AND POWER CABLE WAS COMPLETED WITH VISUAL AND FUNCTIONAL INSPECTION. THE AC ADAPTER INVOLVED IN THE INCIDENT WAS NOT AVAILABLE TO TEST, AS IT WAS DISCARDED BY THE PATIENT. THE FREESTYLE COMFORT WAS FOUND TO BE FUNCTIONAL AND PRODUCING ACCEPTABLE OXYGEN CONCENTRATION LEVELS WHEN POWERED BY A REPLACEMENT AC ADAPTER.

    Additional Manufacturer Narrative · 0

    CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION AND IS ATTEMPTING TO GATHER MORE INFORMATION ABOUT THE INCIDENT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED THE BELOW REPORT FROM LINCARE: THE PATIENT CALLED LINCARE ON (B)(6) 2022 AND SAID THAT THE AC ADAPTER TO THE FREESTYLE COMFORT WAS IN A WALL OUTLET, NOT PLUGGED UP TO THE CONCENTRATOR. THE AC ADAPTER CAUGHT FIRE FROM THE WALL OUTLET. THE FIRE DEPARTMENT WAS CALLED AND DISPATCHED TO THE HOUSE. LINCARE WAS UNABLE TO VERIFY ANY DAMAGE INSIDE OF THE HOUSE OR TO THE PATIENT AS THE PATIENT DOESN'T ALLOW ANYONE INSIDE OF HER HOME DUE TO MEDICAL REASONS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED THE BELOW REPORT FROM (B)(4): THE PATIENT CALLED (B)(4) ON (B)(6) 2022 AND SAID THAT THE AC ADAPTER TO THE FREESTYLE COMFORT WAS IN A WALL OUTLET, NOT PLUGGED UP TO THE CONCENTRATOR. THE AC ADAPTER CAUGHT FIRE FROM THE WALL OUTLET. THE FIRE DEPARTMENT WAS CALLED AND DISPATCHED TO THE HOUSE. (B)(4) WAS UNABLE TO VERIFY ANY DAMAGE INSIDE OF THE HOUSE OR TO THE PATIENT AS THE PATIENT DOESN'T ALLOW ANYONE INSIDE OF HER HOME DUE TO MEDICAL REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499087 FREESTYLE COMFORT CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS200-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female