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

Model Number	IO-400
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital due to low oxygen from their device.The patient has emphysema and the issue initially occurred at the patient's home.Patient stated they had a stationary oxygen concentrator as a backup.Patient received their replacement device and is doing fine.The inogen team attempted to inquire for additional information but the patient declined.
Additional Manufacturer Narrative
B3: date of event is estimated the unit was received with a complaint of noisy.Upon inspection, it was found that the unit had been dropped, resulting in a cracked top housing on the cannula side and a broken column receptacle, indicating high-impact damage.The unit also produces low oxygen levels due to contaminated zeolite, likely related to its age.Additionally, a strong cigarette odor was detected coming from the unit.All tubing and housing were replaced.Evidence of user abuse was noted.

• 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 (Section G): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 22681137
• Report Number: 3004672275-2025-00112
• Device Sequence Number: 18429240
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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
• Device Model Number: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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; Other
• Patient Sex: Unknown