MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information but was declined.The unit came in for system error.Compliant confirmed with data log and power board damaged due to wear and tear on gold pads that caused error 16.Leaking product manifold due to debris under the check valve and that caused external 02 low.
Event or Problem Description
It was reported tat the patient's device was showing the system error.As a result, the patient was experiencing difficulty breathing.A replacement device was sent to the patient is doing fine.No additional information is available at this time as the patient declined further follow-up.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 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: 25486654
• Report Number: 3004672275-2026-00155
• Device Sequence Number: 9735015
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• 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
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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