BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE 3

    MDR report key: 10022326 · Received May 4, 2020

    Report

    Report Number
    3004972304-2019-00051
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    August 13, 2019
    Report Date
    December 13, 2019
    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." THE UNIT WAS RETURNED FOR AN EVALUATION. THE FAILURE DESCRIBED BY THE ADVERSE EVENT FORM COULD NOT BE REPLICATED WHILE TESTING THE FREESTLYE 3 PORTABLE OXYGEN CONCENTRATOR. INSPECTIONS, BOTH EXTERNAL AND INTERNAL, SHOWED NO DAMAGE BEYOND NORMAL WEAR AND TEAR THAT WOULD INDICATE THE OCCURRENCE OF FIRE OR THE PRESENCE OF SMOKE. FUNCTIONAL TESTING SHOWED THAT THE UNIT PERFORMS POORLY, HOWEVER THERE WAS NO INFORMATION PROVIDED OR EVIDENCE FOUND THAT WOULD LINK THE UNIT'S PERFORMANCE TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 12/13/2019, AND IS BEING RESUBMITTED ON 5/4/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. THE UNIT STARTED SMOKING WHILE CHARGING. CUSTOMER DID NOT TRY CHARGING UNIT AGAIN. NOT SURE AS TO WHERE THE SMOKE WAS COMING FROM. THE CUSTOMER TRIED TO USE THE UNIT BUT IT WOULD NOT WORK AND NOTICED THE SMELL OF SMOKE. NO INJURIES WERE SUSTAINED.

    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 09/26/2019, AND IS BEING RESUBMITTED ON 5/4/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. THE UNIT STARTED SMOKING WHILE CHARGING. CUSTOMER DID NOT TRY CHARGING UNIT AGAIN. NOT SURE AS TO WHERE THE SMOKE WAS COMING FROM. THE CUSTOMER TRIED TO USE THE UNIT BUT IT WOULD NOT WORK AND NOTICED THE SMELL OF SMOKE. NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484369 FREESTYLE 3 OXYGEN CONCENTRATOR, PORTABLE CAW CAIRE INC. AS095-3

    Patients

    Seq Age Sex Outcome Treatment
    1