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
Event or Problem Description
The patient reported that her assembly, concentrator, g4 bt unit was noisy while she was using it.She awoke during the night feeling unwell and noted that the unit was not functioning, with her blood oxygen level reading at 65%.When she attempted to reactivate the unit, it produced a sound similar to walking on gravel, failed to concentrate air, and did not charge the battery.Although the patient typically keeps the alarms activated and is responsive to them, no alarms[?]audible or visual[?]were triggered during the incident.Following the event, the patient confirmed she did not go to the hospital despite experiencing weakness, as she lives alone.She continues on 24-7 oxygen therapy and had an alternative oxygen supply available during the device failure.A replacement unit was provided to her the next day, and all necessary reporting requirements have been addressed.
Additional Manufacturer Narrative
According to the patient the unit malfunctioned while in use, resulting in the patient's oxygen level dropping to 65%; a replacement unit was provided the following day.

• Brand Name: INOGEN ONE G4
• Common Device Name: INOGEN ONE G4
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rc; plano TX 75074
• Manufacturer Contact: kevin ford
• MDR Report Key: 21688582
• Report Number: 3004672275-2024-00091
• Device Sequence Number: 9420197
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Remedial Action: Replace
• 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: 10/15/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2022
• 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