MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G4

Model Number	IO-400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement unit has been sent to the patient.
Event or Problem Description
The patient was on a plane when their oxygen concentrator unit overheated, causing the patient to be without oxygen for approximately 5 minutes.As a result, the patient experienced difficulty breathing, prompting the plane to deplane the patient upon landing.The patient was transported to a hospital in (b)(6) co, where they were admitted for 4 days.During the hospital stay, the patient received breathing treatments, antibiotics, inhalers, and oxygen therapy.The patient was diagnosed with co2 poisoning and continues to receive treatment, with a follow-up appointment scheduled.

• Brand Name: INOGEN ONE G4
• Common Device Name: INOGEN ONE G4
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford
• MDR Report Key: 21688679
• Report Number: 3004672275-2024-00077
• Device Sequence Number: 15773551
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown