MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G4

Model Number	IO-400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement unit has been received by the patient.
Event or Problem Description
The patient reported an inability to tolerate the odor emitted by the assembly, concentrator, g4 device, describing it as having a burning or toxic smell.During an outing, she activated the machine but was unable to use it due to the odor.This caused her to experience shortness of breath and a sense of suffocation.The device did not emit any audible or visual alarms during the incident, and she had an alternative oxygen supply available.Upon follow-up, the patient confirmed that she did not need hospitalization and experienced no adverse health effects.She is currently stable, on continuous oxygen therapy at level 2, and doing well.A replacement unit was dispatched the following day and has been received by the patient.All necessary reporting submissions related to the event have been completed.

• Brand Name: INOGEN ONE G4
• Common Device Name: INOGEN ONE G4
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford
• MDR Report Key: 21688866
• Report Number: 3004672275-2024-00087
• Device Sequence Number: 9234505
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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: Other
• Patient Sex: Unknown