MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had become hospitalized.However, there was no additional information at the time of event to attribute the adverse event being related to the device.Once the product was returned and investigated, it was discovered that there was an oxygen issue.Further review of the initial call revealed that patient had called from the hospital stating that the unit had stopped producing oxygen even after replacing the columns.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit came for oxygen error.The complaint was confirmed with the data log show 02 low this means the product manifold leak due to debris under the check valve.The data log shown battery low errors this means the patient running the unit on low battery.Lower housing is broken due to compressor vibration.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 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: 23659284
• Report Number: 3004672275-2025-00175
• Device Sequence Number: 9961701
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/26/2025

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-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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: Hospitalization
• Patient Sex: Unknown