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

Model Number	IO-500
Medical Device Problem Codes	Overheating of Device (1437); No Flow (2991); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Tachycardia (2095); Low Oxygen Saturation (2477)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit was overheating and stopped producing oxygen.As a result, the patient was not receiving enough oxygen and it caused shortness of breath and their heart rate to increase.The patient was able to make it back to their house where they have a backup unit troubleshooting did not resolve the issue.The patient was sent a replacement unit and it is working for them.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on (b)(6) 2026.The unit was returned with reported system hot, which was not confirmed upon inspection, but muffler was blocked and filled with dust; it causes low flow.Internal 02 reading measured 92%, while the external 02 reading measured 87%.And psa-10 that indicates column is contaminated with moisture; it contributed to the low oxygen level.Low flow product manifold duo to debris inside.Leak from cannula barb possible dropped unit.Housing & uip was dirty & scratched due to probable rough cleaning.

• 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: 50508386
• Report Number: 3004672275-2026-00274
• Device Sequence Number: 15810574
• Product Code: CAW
• UDI-Device Identifier: 00817131020162
• UDI-Public: (01)00817131020162
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/28/2026

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?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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