BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE INTENSITY 10

    MDR report key: 10057539 · Received May 14, 2020

    Report

    Report Number
    3004972304-2019-00028
    Event Type
    Death
    Date Received
    May 14, 2020
    Date of Event
    April 4, 2019
    Report Date
    September 20, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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." WE WERE NOTIFIED THAT THE END USER PASSED DUE TO A HEART ATTACK AND USING THE NEWLIFE DID NOT CAUSE HER PASSING.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 9/20/2019, AND IS BEING RESUBMITTED ON 5/21/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. HUSBAND WENT TO THE STORE AND LEFT WIFE AT HOME FOR 20 MINS. FOUND WIFE DECEASED ON FLOOR WITH CANNULA NEXT TO WIFE. THE NEWLIFE 10 WAS NOT IN THE ROOM WITH WIFE, ACCORDING TO EMPLOYEE FROM ROCKY MOUNT OXYGEN REPAIR. PROVIDER ASKED ABOUT GETTING THE UNIT OR DROPPING BY TO CHECK 02. HUSBAND SAYS HE CONTACTED A LAWYER AND WILL HOLD ON TO THE NEWLIFE FOR NOW. ALSO, HUSBAND THINKS HIS WIFE WAS ATTEMPTING TO GET BACK UP OXYGEN DUE TO THE NEWLIFE HAVING AN ORANGE LIGHT ON.

    Additional Manufacturer Narrative · 1

    UNIT IS NOT BEING RETURNED FOR EVALUATION. THE END USER HAS CONTACTED A LAWYER AND IS HOLDING ONTO THE UNIT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 5/10/2019, AND IS BEING RESUBMITTED ON 5/14/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. HUSBAND WENT TO THE STORE AND LEFT WIFE AT HOME FOR 20 MINS. FOUND WIFE DECEASED ON FLOOR WITH CANNULA NEXT TO WIFE. THE NEWLIFE 10 WAS NOT IN THE ROOM WITH WIFE, ACCORDING TO EMPLOYEE FROM (B)(6). PROVIDER ASKED ABOUT GETTING THE UNIT OR DROPPING BY TO CHECK 02. HUSBAND SAYS HE CONTACTED A LAWYER AND WILL HOLD ON TO THE NEWLIFE FOR NOW. ALSO, HUSBAND THINKS HIS WIFE WAS ATTEMPTING TO GET BACK UP OXYGEN DUE TO THE NEWLIFE HAVING AN ORANGE LIGHT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523274 NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 Death