BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 14355550 · Received May 11, 2022

    Report

    Report Number
    3015238204-2022-00049
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 17, 2022
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020032
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. INOGEN'S INVESTIGATION OF THE DEVICE IS COMPLETE. THIS UNIT IS RUNNING NORMALLY AND AS DESIGNED. INOGEN WILL WRITE A SUPPLEMENTAL FILING WITH ANY ADDITIONAL INFORMATION GATHERED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G1. ADDITONAL INFORMATION GATHERED VIA PATIENT, MENTIONED INOGEN ONE PORTABLE CONCENTRATOR AT NO TIME STOPPED WORKING, AS THERE WAS NO DEVICE MALFUNCTION. REPORTEDLY, PATIENT WAS NOT WEARING HER OXYGEN FOR AN UNKNOWN REASON WHEN THE EVENT HAPPENED. THEREFORE, THE EVENT WAS UNRELATED TO THE UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED NO OXYGEN OUTPUT FROM THE DEVICE. IN TURN, THE PATIENT SWITCHED UNITS AND LATER EXPERIENCED "SYSTEM HOT ERROR MESSAGE." AS A RESULT, THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790663 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. 840 00817131020032

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Hospitalization