MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Headache (1880); Low Oxygen Saturation (2477)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was persistently displaying the system error message and was not providing enough oxygen.It was noted that the patient was experiencing a headache due to the event.As a result, the patient went to the doctor where they were given oxygen.Patient then went home to their stationary device and was stable.Patient has since received their replacement device and is doing better.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was received with a reported system error, which was confirmed found blocked muffler due to ball muffler stacked in the center element muffler.Diagnostic screen shows psa-13 and multiple error 16b on the data log.The internal 02 reading measured 81.6%, while the external 02 reading measured 80.2%.The issue was caused by blocked mufflers and zeolite contamination due to absorbing moisture.Replaced muffler and columns to resolve the issue.And top housing has cosmetic issues, replace it.

• 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: 24968807
• Report Number: 3004672275-2026-00111
• Device Sequence Number: 10580420
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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; Life Threatening
• Patient Sex: Unknown