MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G3

Model Number	IO-300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information available.
Event or Problem Description
A routine system alert had been displayed[?] an "o2 service soon" message[?] indicating that the unit's columns were over four years old.The patient stated that they experienced an unexpected dizzy spell, the episode led to a fall while using the portable oxygen concentrator.The impact may have triggered the device's alert, but the sequence of events remained uncertain.The patient sustained a gash on her head, requiring a visit to the hospital, where she remained for the day.The patient does not believe the dizziness was caused by the unit.The device in question was a g3 concentrator.Multiple attempts to contact the patient were made via phone and email but were unsuccessful.

• Brand Name: INOGEN ONE G3
• Common Device Name: INOGEN ONE G3
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688185
• Report Number: 3004672275-2025-00035
• Device Sequence Number: 18355332
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/14/2025

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?: No
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2014
• 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