MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The return reason of oxygen error is confirmed since zeolite is found contaminated, which is possibly caused when it absorbs the moisture.
Event or Problem Description
It was reported that when the patient went to go to their appointment, the patient felt like they were suffocating while using the device.No error messages were seen on the device.As a result, the patient was sent to the hospital emergency room and was put on their oxygen.When the patient left to their vehicle, the patient started feeling like they were suffocating again so they were put on the hospital oxygen again.The patient was sent home with an oxygen tank given.Patient has since received their replacement.

• Brand Name: INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 25846656
• Report Number: 3004672275-2026-00204
• Device Sequence Number: 13385021
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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: Life Threatening
• Patient Sex: Unknown