BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 14464742 · Received May 21, 2022

    Report

    Report Number
    3004972304-2022-00014
    Event Type
    Death
    Date Received
    May 21, 2022
    Date of Event
    March 20, 2022
    Report Date
    August 24, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. A THIRD PARTY INVESTIGATION WAS CONDUCTED AT THE SCENE OF THE INCIDENT. THE EXPERTS NOTED THAT THERE WERE SMOKING MATERIALS OBSERVED AT AND NEAR THE AREA OF ORIGIN OF THE FIRE, AND THERE IS EVIDENCE POINTING TO SMOKING BEING THE CAUSE OF THE INCIDENT.

    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. 7/12/2022: A THIRD PARTY INVESTIGATION WAS CONDUCTED AT THE SCENE OF THE INCIDENT. THE EXPERTS NOTED THAT THERE WERE SMOKING MATERIALS OBSERVED AT AND NEAR THE AREA OF ORIGIN OF THE FIRE, AND THERE IS EVIDENCE POINTING TO SMOKING BEING THE CAUSE OF THE INCIDENT. 8/24/2022: A THIRD PARTY INVESTIGATION WAS CONDUCTED ON 7/21/2022 TO EXAMINE EVIDENCE. CIRCUMSTANTIAL EVIDENCE POINTS TO THE PATIENT ENGAGING IN SMOKING-RELATED ACTIVITY AT THE TIME OF THE FIRE. THE BURN PATTENS CLEARLY INDICATE THE SOURCE OF THE FIRE WAS EXTERNAL TO THE CONCENTRATOR.

    Additional Manufacturer Narrative · 0

    CAIRE IS COORDINATING A THIRD PARTY INVESTIGATION OF THIS ADVERSE EVENT AND THE DEVICE INVOLVED. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON APRIL 22, 2022, CAIRE WAS NOTIFIED OF THE BELOW INCIDENT BY (B)(6): THE UNIT WAS INVOLVED IN A HOUSE FIRE. AT THE TIME OF THE FIRE, THERE WAS AN O2 CONCENTRATOR IN USE BY THE PATIENT, WHICH WAS MANUFACTURED BY CAIRE INC. THE CAIRE O2 CONCENTRATOR WAS PURCHASED FROM AND/OR SUPPLIED BY COMMUNITY SURGICAL SUPPLY. THE PATIENT PASSED AWAY FROM INJURIES FROM THE FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153167 NEWLIFE ELITE CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS005-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death