MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dyspnea (1816); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement unit was issued.
Event or Problem Description
The patient explained that they were hospitalized because a part of their oxygen unit broke, leaving them without oxygen at home.The unit stopped working, and due to a previous diagnosis of pulmonary embolism, the patient couldn't breathe on their own.They had no other source of oxygen because their backup unit had malfunctioned the day before.Consequently, the patient had to spend two extra nights in the hospital until a replacement unit was delivered.

• Brand Name: INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3HF 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: 21688714
• Report Number: 3004672275-2024-00030
• Device Sequence Number: 8850156
• Product Code: CAW
• UDI-Device Identifier: 00817131020100
• UDI-Public: (01)00817131020100
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: IO-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown