MAUDE Adverse Event Report: INOGEN INC. INOGEN AT HOME OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 15-jan-2026.There is no confirmation for the return reason of oxygen error based on the internal and external oxygen level.However, the compressor is noisy, which possibly caused due to loose compressor housing.
Event or Problem Description
It was reported that the patient's unit was not producing enough oxygen and the patient was not getting enough oxygen.As a result, the patient noted that their hands started to turn blue.The unit started working again and their hands went back to normal.They did not have to be hospitalized due to the event.They received their replacement and it is working for them.

• 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: 24192600
• Report Number: 3004672275-2026-00019
• Device Sequence Number: 7975552
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• 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): 01/27/2026

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: GS-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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: Other
• Patient Sex: Unknown