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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further contact would be needed to obtain a complete understanding of the event.
Event or Problem Description
The patient was hospitalized for shortness of breath and did experience any adverse health consequences because of the event.The patient reported experiencing shortness of breath.Attempts to contact the patient for additional information were made three times via phone and email but were unsuccessful.The details of her hospitalization about how they got there, the length of stay, or specifics of the hospital visit remain unclear, as well as treatment, medications, or testing.It is unknown if the event has been resolved, whether the patient is experiencing any ongoing complications, or if follow-up is needed.Details about the patient's prescribed oxygen usage, device settings, and whether any alarms were active during the incident have not been confirmed.It's also unclear if an alternative oxygen supply was available or if a replacement unit has been received.

• 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 ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688568
• Report Number: 3004672275-2024-00101
• Device Sequence Number: 9419707
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• 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): 12/04/2024

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: 11/06/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: Hospitalization
• Patient Sex: Unknown