BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 20268930 · Received September 20, 2024

    Report

    Report Number
    3004672275-2024-00068
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 17, 2024
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020063
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT, THE UNIT WAS ON THE SIDE OF HER WHEELCHAIR WHEN THE UNIT OVERHEATED AND IT FELT LIKE IT BURNT HER. SHE DID NOT HAVE A NOTICEABLE BURN AND DID NOT GO TO THE HOSPITAL. THERE WAS NO TREATMENT REQUIRED. SHE STATED SHE DID NOT SUFFER FROM ANY OTHER MEDICAL CONDITION/CHANGES DUE TO THIS INCIDENT. THERE WERE NO AUDIBLE OR VISUAL ALARMS ON THE DEVICE AT THE TIME OF THE EVENT. SHE DID HAVE AN ALTERNATIVE OXYGEN SUPPLY FOR USE DURING DEVICE ISSUE. SHE IS USING O2 @ 3L 24/7 ON A PORTABLE UNIT AND DOES HAVE A BACKUP UNIT AT HOME. A REPLACEMENT UNIT WAS RECEIVED 2 DAYS LATER. SHE DID RETURN THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497168 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other