BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWLIFE INTENSITY

    MDR report key: 17195474 · Received June 23, 2023

    Report

    Report Number
    3004972304-2023-00011
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 23, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    PER DISTRIBUTOR'S REPORT: PATIENT WAS SMOKING WITH OXYGEN ON/IN USE. PATIENT WAS TRANSPORTED TO THE HOSPITAL AT UCSD BURN UNIT FOR TREATMENT OF HER BURN INJURIES OF VARIOUS DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865890 NEWLIFE INTENSITY CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization