MAUDE Adverse Event Report: INOGEN, INC INOGEN AT HOME; Generator, oxygen, portable

Model Number	GS-100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned and an investigation is required.
Event or Problem Description
The patient reported a malfunction with the inogen at home unit.She was experiencing difficulty breathing, with a rapid respiratory rate and an oxygen level of 82% while using her portable oxygen concentrator (poc).Due to her condition, the patient was unable to troubleshoot the issue and requested that 911 be called.A reportability assessment was completed, and all required reporting submissions were made.Three subsequent attempts by inogen were made to contact the patient but were unsuccessful.

• Brand Name: INOGEN AT HOME
• Common Device Name: Generator, oxygen, portable
• Manufacturer (Section D): INOGEN, INC; 600 shiloh; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688677
• Report Number: 3004672275-2024-00071
• Device Sequence Number: 18462175
• Product Code: CAW
• UDI-Device Identifier: 00817131020131
• UDI-Public: (01)00817131020131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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?: Yes
• Device Model Number: GS-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown