MAUDE Adverse Event Report: INOGEN, INC. INOGEN AT HOME OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.There is no confirmation for the return reason of oxygen error.No trouble found.Ran the unit for 24 hours - no errors popped up or recorded on the data log.The unit is working well and within specification this report was originally sent on dec 9, 2025, but was not accepted due to there already being a report with a duplicate report number.
Event or Problem Description
It was reported that the patient's device was not producing enough oxygen for them.It was noted that the patient's oxygen levels were decreasing and were having trouble breathing.Troubleshooting was unable to resolve the issue.As a result, the patient was hospitalized due to the issue exacerbating their lung condition (pulmonary fibrosis).A replacement device has been sent to the patient and the patient has left the hospital since it was received.

• Brand Name: INOGEN AT HOME OXYGEN CONCENTRATOR
• Common Device Name: INOGEN AT HOME 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: 23967235
• Report Number: 3004672275-2026-00003
• Device Sequence Number: 4888202
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• 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): 01/05/2026

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: GS-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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; Life Threatening
• Patient Sex: Unknown