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	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on (b)(6) 2026.There is no confirmation for the return reason of no power.Motherboard's j9 is broken, which possibly caused when is dropped.Feed waste manifold failed due to valve stuck.Zeolite existed in the manifold and fouled the valves.
Event or Problem Description
It was reported that the patient's unit stopped working and was not producing enough oxygen.As a result, the patient's oxygen levels dropped and the patient was taken to the emergency room and later admitted to the hospital.They were discharged after three days and they are recovering.A replacement unit was sent to the patient and it is working for them.

• 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: 25867274
• Report Number: 3004672275-2026-00211
• Device Sequence Number: 10585211
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/19/2026

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: 07/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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; Life Threatening
• Patient Sex: Unknown