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

Model Number	IO-400
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was not recognizing the battery when they were out shopping.As a result, the patient experienced difficulty breathing.A replacement device was sent to the patient.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.
Additional Manufacturer Narrative
The inogen team attempted to contact the patient for further information three times with no response.The unit came in for battery board damage.Compliant confirmed with battery board damaged possibly the unit dropped / high impact.Scratch top housing is probably rough cleaning and lower housing is torn mount due to compressor vibration.The data log shows battery low -the customer running the unit on low battery, error 1 popup this is the indication of empty battery.Product manifold leak due to debris inside under check valve.Feed waste broken probably has dropped /high impact.

• 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: 24912649
• Report Number: 3004672275-2026-00103
• Device Sequence Number: 9085803
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/17/2026

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: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2026
• 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: Life Threatening
• Patient Sex: Unknown