MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G3

Model Number	IO-300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An alternative home oxygen unit was available for use.A replacement unit was provided via overnight delivery.
Event or Problem Description
A unit was reported to be displaying a temperature error, leading to operational failure.The patient's machine shut down while in route to a doctor's appointment, and upon arrival at the doctor's office, the unit would not stay on.The patient, who is prescribed 24/7 oxygen at a setting of 6, was unable to breathe independently.As a result, the doctor's office called an ambulance, and the patient was admitted to the hospital, where they remained for six days.The patient confirmed experiencing adverse health consequences due to the incident.During hospitalization, the patient received breathing treatments, supplemental oxygen, and antibiotics.Additional patient details indicate pre-existing conditions, including copd, emphysema, and lung cancer, which may have contributed to the severity of the health event.The patient did not observe any audible or visual alarms on the device at the time of the incident other than the temperature error.

• Brand Name: INOGEN ONE G3
• Common Device Name: INOGEN ONE G3
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688199
• Report Number: 3004672275-2025-00018
• Device Sequence Number: 8850148
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/06/2025

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-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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