BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAINOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19658772 · Received July 2, 2024

    Report

    Report Number
    3004672275-2024-00039
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 27, 2024
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN OF THE DEVICE HAS BEEN INITIATED. ONCE THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENTS DAUGHTER, THE PATIENTS UNIT WAS PLACED ON HER SIDE AND BURNED HER UPPER THIGH WHILE SITTING IN THE WHEELCHAIR. THE UNIT BECAME EXTREMELY HOT, THE HEAT PENETRATED GARMENTS AND BURNED HER SKIN. PATIENT WAS UNABLE TO VERBALIZE THAT UNIT WAS BURNING HER SKIN. WOUND CARE HAD TO BE CONSULTED TO TAKE CARE OF THE BURN. SHE ALSO INDICATED THAT THE PERSON TAKING CARE OF HER MOM WAS A NEW HIRE. THE PATIENTS DAUGHTER STATED THAT THE NURSING HOME CONDUCTED TRAINING FOR ALL STAFF TO REST THE UNIT ON GROUND AND AWAY FROM PATIENT'S BODY TO AVOID BURN. ADDITIONALLY, DAUGHTER STATED THAT HER MOTHER HAD A RAPID DECLINE IN HEALTH SINCE DECEMBER DUE TO THE ALZHEIMER'S DISEASE, HER O2 NEEDS HAD INCREASED AND DEVICE SETTING WAS CHANGED FROM 2 TO SETTING OF AROUND 4-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507689 LAINOGEN G5 PORTABLE OXYGEN CONCENTRATOR INOGEN G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-500 00817131020162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other