BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 7484593 · Received May 3, 2018

    Report

    Report Number
    3004972304-2018-00012
    Event Type
    Death
    Date Received
    May 3, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 UNIT WAS RETURNED FOR AN EVALUATION. THE DEVICE DOES NOT OPERATE AS INTENDED DUE TO MISSING COMPONENTS, LEAKS, AND HEAVY CONTAMINATION. THE DEVICE REQUIRES REPAIR AND MAINTENANCE.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/17/2018, AND IS BEING RESUBMITTED ON 4/8/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. THE OXYGEN CONCENTRATOR HAD BEEN WORKING CORRECTLY, AND WAS GIVEN ITS PERIODIC SERVICE ON MAY 18TH 2017. IT APPEARS TO HAVE STOPPED WORKING AFTERWARDS. THE DEVICE USER WAS FOUND IN A DETERIORATED STATE, AND ACCORDING TO HER HUSBAND, NO GAS WAS COMING OUT OF THE MASK ATTACHED TO THE CONCENTRATOR. SADLY, THE DEVICE USER PASSED AWAY ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    WE ARE ATTEMPTING TO GET THE UNIT BACK FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE OXYGEN CONCENTRATOR HAD BEEN WORKING CORRECTLY, AND WAS GIVEN ITS PERIODIC SERVICE ON (B)(6) 2017. IT APPEARS TO HAVE STOPPED WORKING AFTERWARDS. THE DEVICE USER WAS FOUND IN A DETERIORATED STATE, AND ACCORDING TO HER HUSBAND, NO GAS WAS COMING OUT OF THE MASK ATTACHED TO THE CONCENTRATOR. SADLY, THE DEVICE USER PASSED AWAY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327974 NEWLIFE ELITE CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS005-231

    Patients

    Seq Age Sex Outcome Treatment
    1 Death