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

Model Number	IO-400
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the patient, he was on a bus tour when the unit stopped working.He reported feeling sick and out of breath so he was taken to the nearest hospital.At the hospital he was given oxygen and medicine.He stated that the unit displayed a system error and stopped working.The patient has a history of copd.He also reported that he received a replacement unit.
Additional Manufacturer Narrative
A return of the device has been initiated.Once the device is received an investigation will be conducted and a follow up will be submitted if required.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21464049
• Report Number: 3004672275-2025-00024
• Device Sequence Number: 3492078
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/25/2025

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-400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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