BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWLIFE INTENSITY

    MDR report key: 16986020 · Received May 23, 2023

    Report

    Report Number
    3004972304-2023-00009
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 23, 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 INC. HAS MADE THREE UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE DEVICE FOR EVALUATION. CAIRE INC. WILL SUBMIT A FOLLOW UP REPORT IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION. THE ADVERSE EVENT DESCRIPTION STATES THAT THE PATIENT WAS SMOKING WHILE THE UNIT WAS OPERATING. NO SMOKING WARNINGS WERE REVIEWED AND DEEMED ADEQUATE. "NO SMOKING" SYMBOLS ARE AFFIXED TO THE FACE OF THE UNIT AND "NO SMOKING" WARNINGS ARE INCLUDED IN THE IFU.

    Description of Event or Problem · 0

    AS REPORTED: PATIENT WAS AT HOME AND IS A&O X3. PATIENT UTILIZES 10L O2 VIA NASAL CANNULA. PATIENT'S SISTER WAS VISITING FROM OUT OF STATE AND PROVIDED THE PATIENT WITH A CIGARETTE. UPON LIGHTING THE CIGARETTE, O2 IGNITED AND PATIENT RECEIVED SECOND DEGREE BURNS TO NOSE AND FACE. PATIENT'S SISTER CALLED 911 AND PATIENT WAS SENT TO HALIFAX DAYTONA BEACH VIA EMS AND THEN TRANSFERRED TO ORMC BURN UNIT. PATIENT WAS ADMITTED FOR LESS THAN 24 HOURS AND DISCHARGED AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449523 NEWLIFE INTENSITY CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening| H