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

Model Number	IO-400
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information three times with no response.The unit came in for system hot.The complaint was confirmed with last error recall register as a "system hot warning".This is possibly caused by the blocked vent on the unit.The unit also produces low oxygen levels due to contaminated zeolite.The psa cycle counts (according to the data log) being high is an indication the zeolite is getting contaminated by moisture.Additionally, broken cannula barb due to high impact, possibly dropped the unit.Top housing and lower housing replaced due cosmetic damage.
Event or Problem Description
It was reported that the patient's device was not operating properly and the cannula barb had broken while at church.The system hot message was noted.As a result, the patient went to the hospital due to the device.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

• 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: 24967799
• Report Number: 3004672275-2026-00110
• Device Sequence Number: 4954166
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 04/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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; Life Threatening
• Patient Sex: Unknown