MAUDE Adverse Event Report: Inogen, Inc. Inogen One G5 Portable Oxygen Concentrator

Model Number	IO-500
Medical Device Problem Codes	Premature Discharge of Battery (1057); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was not working properly and the battery was depleting quickly.It caused the patient to experience shortness of breath and their oxygen levels to drop.Patient did not have a backup at the time of the event.As a result, the patient was admitted to the hospital for 15 days.Patient has since been released from the hospital and has received a replacement device.
Additional Manufacturer Narrative
B3: date of event is estimated.As the device is not returned, no other information is available at this time to determine any other probable cause and/or the exact cause of the event.If the device is received an investigation will be conducted and a follow up will be submitted if required.

• Brand Name: Inogen One G5 Portable Oxygen Concentrator
• Common Device Name: Inogen One G5 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: 50457467
• Report Number: 3004672275-2026-00268
• Device Sequence Number: 18702480
• Product Code: CAW
• UDI-Device Identifier: 00817131020162
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• 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: Life Threatening; Hospitalization
• Patient Sex: Unknown