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

Model Number	IO-400
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 16-mar-2026.The unit received a reported oxygen error, which was unable to record the data due to shut down the unit by error 4(b) it causes valve stuck feed waste manifold.And data loge shows 02 low and sieve warning due to high psa-(10).The issue was caused by low columns efficiency, that indicates columns contamination due to zeolite absorbed too much moisture.
Event or Problem Description
It was reported that the patient's unit had a low oxygen error message.Troubleshooting did not resolve the issue and as a result, the patient had difficulty breathing.It was also reported that unit was not producing any oxygen at the time of the event.Subsequently, a few days later, the patient had a copd flare-up and had to be hospitalized.It is unclear if the unit was the direct cause, but this is being reported out of an abundance of caution.The patient was moved from the hospital to a rehab facility.The replacement unit was received and it is working well for them.

• Brand Name: INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 BLUETOOTH 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: 24794673
• Report Number: 3004672275-2026-00076
• Device Sequence Number: 15654753
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• 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): 04/06/2026

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: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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