BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19731444 · Received July 12, 2024

    Report

    Report Number
    3004672275-2024-00016
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    February 19, 2024
    Report Date
    July 12, 2024
    Manufacturer
    INOGEN
    Product Code
    CAW
    UDI-DI
    00817131020063
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO INOGEN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS PROVIDED

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT, HE WAS HAVING A COPD EXACERBATION EVENT WITH PNEUMONIA. OXYGEN LEVEL DROPPED TO 84. THE POC STOPPED PRODUCING OXYGEN ON THE WAY TO THE ER. THE ALERT STATED CHECK CANNULUS. THE PATIENT CHECKED ALL CONNECTIONS AND THERE WAS STILL NO OXYGEN. THE PATIENT FRANTICALLY STOPPED AT A FIRESTATION AND THE FIREFIGHTERS GAVE HIM OXYGEN AND TRANSPORTED HIM TO THE HOSPITAL IN CRITICAL SHAPE. HE SPENT 6 DAYS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235594 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization