MAUDE Adverse Event Report: Inogen Inc. Inogen One G4 Bluetooth Portable Oxygen Concentrator

Model Number	IO-400
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	06/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit shuts down after a few seconds of being switched on.Troubleshooting did not resolve the issue.As a result, the patient stated that they had ambulatory issues without the use of their portable oxygen concentrator, however they were not hospitalized due to this.The inogen team attempted to contact the patient for further information three times with no response.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was returned for evaluation on 09-jul-2026.The unit was returned with a no power complaint, which was confirmed during testing.The unit shut down after a few minutes due to damaged power input (damaged gold pad).Additionally, the compressor has high power due to bad piston seal.

• Brand Name: Inogen One G4 Bluetooth Portable Oxygen Concentrator
• Common Device Name: Inogen One G4 Bluetooth 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: 50055247
• Report Number: 3004672275-2026-00218
• Device Sequence Number: 10636180
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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