MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.Unit came in for service needed.The complaint was confirmed with data log.The data log shows o2 low that caused by contaminated zeolite absorbed too much moisture and feed waste valve stuck due to debris inside.Damage mount plate due to compressor vibration.Control panel broken due to overtightening canula barb.
Event or Problem Description
It was reported that the patient's device kept turning off by itself while driving, leading to the patient experiencing shortness of breath and lowered oxygen concentration.As a result, the patient drove to er where they were admitted for a couple of hours.During the er visit, troubleshooting was performed by connecting and reconnecting the battery, which helped the issue.Patient has since been released from the er and received their replacement device.

• Brand Name: INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 HIGH FLOW 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: 25248949
• Report Number: 3004672275-2026-00140
• Device Sequence Number: 21488591
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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