MAUDE Adverse Event Report: Inogen, Inc. Inogen One G4 Bluetooth Portable Oxygen Concentrator

Model Number	IO-400
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was shutting off when the patient was in their doctor's office.The system error message was noted on the device.As a result, the patient was feeling dizzy and light headed.A replacement device was sent to the patient.
Additional Manufacturer Narrative
The unit came in for system error and confirm complaint with the diagnostic page unit sieve life indicated low that caused by column contaminated too much absorbed moisture.The data log shows system warm possibly blocked vent.

• 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: 50040889
• Report Number: 3004672275-2026-00214
• Device Sequence Number: 18602917
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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: Life Threatening
• Patient Sex: Unknown