MAUDE Adverse Event Report: INOGEN, INC. INOGEN AT HOME OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the patient, the home unit was not working.She described that the device started to flashlights and then stopped working.She said that she was having difficulty breathing.Her o2 had dropped to 82% which causes her to go to the hospital where she stayed for 3 days.She reported that she did have a portable unit as an alternative oxygen supply.At the hospital she received breathing treatment and supplemental oxygen with antibiotics.The patient has a history of congested heart failure, copd and emphysema.The patient received a replacement 2 days after the event.

• Brand Name: INOGEN AT HOME OXYGEN CONCENTRATOR
• Common Device Name: INOGEN AT HOME 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: 21379064
• Report Number: 3004672275-2025-00020
• Device Sequence Number: 17106150
• Product Code: CAW
• UDI-Device Identifier: 00817131020131
• UDI-Public: (01)00817131020131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: GS-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/13/2025
• 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