BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN AT HOME STATIONARY CONCENTRATOR

    MDR report key: 7441976 · Received April 18, 2018

    Report

    Report Number
    3009843463-2018-00001
    Event Type
    Death
    Date Received
    April 18, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 18, 2018
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K132489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER CALLED INTO INOGEN CUSTOMER CARE TEAM ON (B)(6) 2018 TO INFORM INOGEN THAT HER FATHER HAD PASSED AWAY AND SHE WOULD LIKE TO HAVE AN RMA ISSUED TO RETURN THE EQUIPMENT. THE PATIENT WAS FOUND DECEASED WHILE CONNECTED TO THE INOGEN AT HOME STATIONARY CONCENTRATOR WITH BURN MARKS ON HIS FACE, NECK, EARS, AND NOSE FROM WHAT IS SUSPECTED TO BE AS A RESULT OF THE PATIENT SMOKING. THE PATIENT'S DAUGHTER EXPLAINED THAT CIGARETTES WERE FOUND THROUGHOUT THE HOUSE. THE FIRE DID NOT REACH THE INOGEN AT HOME STATIONARY CONCENTRATOR BUT THE CANNULA & TUBING CONNECTED TO THE DEVICE WAS BURNED. IT SHOULD BE NOTED THAT THE PATIENT'S DAUGHTER HAD STATED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS ASSOCIATED WITH VASCULAR DEMENTIA AND PARKINSON'S DISEASE. THE FIRE DEPARTMENT WAS NOT DISPATCHED AS THE HOME DID NOT CATCH FIRE. THE POLICE WERE DISPATCHED HOWEVER NO POLICE REPORT IS AVAILABLE AT THE TIME THIS REPORT IS BEING FILED. THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283235 INOGEN AT HOME STATIONARY CONCENTRATOR INOGEN AT HOME STATIONARY CONCENTRATOR, NCE (10-05345-XX-XX) CAW INOGEN, INC. GS-100

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death