BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWLIFE ELITE

    MDR report key: 12338788 · Received August 18, 2021

    Report

    Report Number
    3004972304-2021-00020
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    March 23, 2021
    Report Date
    January 3, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. ON 10/6/2021, CAIRE RECEIVED THE MODEL NUMBER AND SERIAL NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT. CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE DAMAGE SUSTAINED BY THE UNIT IN THE FIRE WAS TOO SEVERE TO FIND A ROOT CAUSE. ADDITIONALLY, MANY OF THE UNIT'S COMPONENTS WERE MISSING OR WERE DAMAGED BEYOND RECOGNITION. ADDITIONALLY, THE SERIAL NUMBER AND MODEL NUMBER HAVE BEEN CORRECTED ON THIS REPORT. THE CORRECT SERIAL NUMBER IS (B)(6), AND THE CORRECT MODEL NUMBER IS AS005-232.

    Additional Manufacturer Narrative · 1

    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 IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEWLIFE ELITE CAUGHT FIRE AT THE HOME OF A PATIENT. THE PATIENT SUSTAINED INJURY WHILE REMOVING THE MACHINE INTO THE GARDEN. THE PATIENT REPORTED THAT SHE SUSTAINED PAIN IN HER BACK AND SHOULDER, AND BURNS TO HER FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234350 NEWLIFE ELITE CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS005-232

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other