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

Model Number	IO-300
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's daughter stated the patient was in the hospital due to the unit not working.They stated that the patient's oxygen saturation dropped to 89% and bounced back to 90%.The patient's daughter stated that the patient was unable to get enough oxygen from the unit therefore they were hospitalized.The inogen team attempted to contact the patient for further information three times with no response.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for analysis on 25-nov-2025 and is undergoing investigation.The results of the investigation will be included in a supplemental report once the investigation is completed.
Additional Manufacturer Narrative
The unit was returned for analysis on 25-nov-2025.The return reason of oxygen error is confirmed since compressor had low flow.Possibly due to damaged piston seals; bad piston bearings, bad housing bearing; and debris under flappers of valve plate and piston.

• Brand Name: INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 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: 23659479
• Report Number: 3004672275-2025-00173
• Device Sequence Number: 10124111
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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