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

Model Number	IO-400
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device displayed the low oxygen error and would randomly shut off.The patient went to the doctor and it was noted that the patient had low blood pressure and lowered oxygen concentration.As a result, the patient was sent to the hospital and was admitted for 3 days.Patient has since left the hospital and is doing fine with their replacement device.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit came for oxygen error.The complaint was confirmed by data log and shows error 5.Zeolite absorbed too much moisture caused by column contamination and product manifold leak due to debris inside under check valve that caused by low o2.Compressor power is intermittent due to piston seals and bearing bad.Valve plate flappers open and damaged harness.Feed waste broken probably unit dropped/ high impact.

• 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: 50463931
• Report Number: 3004672275-2026-00264
• Device Sequence Number: 21398539
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 08/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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; Other
• Patient Sex: Unknown