BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWLIFE INTENSITY

    MDR report key: 16844480 · Received May 1, 2023

    Report

    Report Number
    3004972304-2023-00008
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    March 26, 2023
    Report Date
    May 1, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    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 CUSTOMER SERVICE IS ATTEMPTING TO OBTAIN THE UNIT SERIAL NUMBER, ADDITIONAL INFORMATION, AND RETURN OF THE UNIT TO CAIRE'S BALL GROUND, GA FACILITY. THREE ATTEMPTS HAVE BEEN MADE. AN UPDATED REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED: PATIENT WAS SMOKING ON HIS PORCH WITH HIS NASAL CANNULA ON AND O2 CONCENTRATOR RUNNING. PATIENT'S CIGARETTE CAUSED THE O2 TO IGNITE RESULTING IN BURNS TO THE PATIENT'S MOUTH, HAND, NOSE AND NASAL PASSAGE. PATIENT WAS EDUCATED AT EVERY VISIT ON OXYGEN SAFETY AND WAS GIVEN TRAINING MATERIALS INCLUDING A VIDEO AND A HANDOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363954 NEWLIFE INTENSITY CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other