MAUDE Adverse Event Report: Inogen Inc. Inogen At Home Oxygen Concentrator

Model Number	GS-100
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit had white dust coming out of the bottom following a column replacement.It was also reported that the unit was not producing enough oxygen for the patient.As a result, the patient had difficulty breathing and was taken to the er.The patient's oxygen needs may have changed as they decided to go with a higher output machine instead of getting a replacement device.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on (b)(6) 2026.The return reason of oxygen error is confirmed since zeolite dust existed in the unit, which is caused by the breakdown of zeolite particles.This occurs when zeolite rubs against one another.Over time this can lead to multiple errors.This dust is so fine it can escape the column frits and contaminate the muffler with zeolite dust.

• Brand Name: Inogen At Home Oxygen Concentrator
• Common Device Name: Inogen At Home 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: 50218119
• Report Number: 3004672275-2026-00247
• Device Sequence Number: 18715653
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: GS-100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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: Life Threatening; Other
• Patient Sex: Unknown