BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE INTENSITY 10

    MDR report key: 15262905 · Received August 19, 2022

    Report

    Report Number
    3004972304-2022-00029
    Event Type
    Death
    Date Received
    August 19, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 19, 2022
    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. THE NEWLIFE INTENSITY USER MANUAL CONTAINS WARNINGS TO AVOID SMOKING OR OPEN FLAMES NEAR THE DEVICE WHILE IN USE. CAIRE ATTEMPTED TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION BUT DID NOT RECEIVE A RESPONSE FROM THE CUSTOMER. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON JULY 20, 2022, CAIRE RECEIVED A REPORT FROM VITAS HEALTHCARE OF THE BELOW INCIDENT: THE PATIENT WAS REPORTED TO HAVE DIED IN A FIRE REPORTEDLY CAUSED BY SMOKING WHILE USING OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263606 NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death COMMODE| E CYLINDER| E CYLINDER| M CYLINDER| M CYLINDER| NEBULIZER COMPRESSOR| OVER THE BED TABLE| REGULATOR| SHOWER CHAIR| SUCTION RESPIRATORY MACHINE| WALKER-ROLLATOR