MAUDE Adverse Event Report: Inogen Inc. Inogen One G5 Portable Oxygen Concentrator

Model Number	IO-500
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit was not producing enough oxygen following a column replacement resulting in the patient having breathing issues.Initial troubleshooting did resolve the issue, however the error persisted a few days after.A replacement unit was sent to the patient as troubleshooting did not resolve the issue the second time.The inogen team attempted to contact the patient for further information three times with no response.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was not returned for evaluation.

• Brand Name: Inogen One G5 Portable Oxygen Concentrator
• Common Device Name: Inogen One G5 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: 50927193
• Report Number: 3004672275-2026-00315
• Device Sequence Number: 15834064
• Product Code: CAW
• UDI-Device Identifier: 00817131020162
• UDI-Public: (01)00817131020162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/28/2026

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-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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