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

Model Number	IO-400
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr report is being submitted to address issues related specifically to the device's columns for not delivering oxygen as expected.As the columns are consider a disposable accessoryy and are not required to be return for further analysis.The report focuses on the column peformance concerns rather than any malfucntion of the primary device itself.
Event or Problem Description
On (b)(6) 2025 the patient called inogen to report that he was having low oxygen error.The patient confirmed the issues with his oxygen g4 unit while traveling, resulting in hospitalization for 3 days after being out of oxygen for 2 days during a cruise.Per the patient he is back home recovering, he received new columns for the device which it is now functioning well with no issues.

• Brand Name: INOGEN G4 OXYGEN CONCENTRATOR
• Common Device Name: INOGEN G4 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: 23596779
• Report Number: 3004672275-2025-00158
• Device Sequence Number: 9381315
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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