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

Model Number	GS-100
Medical Device Problem Codes	Temperature Problem (3022); Noise, Audible (3273)
Health Effect - Clinical Codes	Burning Sensation (2146); Cough (4457)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 6-nov-2025, however due to a documentation error, it was not investigated.The device investigation has started on 26-nov-2025 and a supplemental report will be submitted once the investigation is completed.
Event or Problem Description
It was reported that the patient stated that the unit was producing a loud grinding noise and was getting a little warm.They also stated that the air they were breathing in caused them to cough and made their throat burn.As a result, the patient was hospitalized where they were provided supplemental oxygen.A replacement unit was sent to the patient.The inogen team attempted to contact the patient for further information three times with no response.
Additional Manufacturer Narrative
The unit was returned for evaluation on 6-nov-2025.The device investigation was completed on 2-dec-2025.There is no confirmation for the return reason of noisy.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.

• 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: 23660287
• Report Number: 3004672275-2025-00174
• Device Sequence Number: 14645038
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: GS-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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