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

Model Number	IO-500
Medical Device Problem Codes	Failure to Charge (1085); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device would shut off by itself after making a noise and that the car charger was not working.As a result, the patient experienced difficulty breathing and was hospitalized.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information three times with no response.The unit came in for no power.The complaint was confirmed with the defective sensor block by water damage that was caused by unit shut down with error 128(b) and data log shows 02 in invalid.Motherboard j 21 and battery board pin damage can have a high impact on the unit (possibly dropped).The data log shows battery low errors; this means patient running unit on low battery.Unit works fine with a good battery.Housing scratch probably user rough cleaning and lower housing broken mount due to compressor vibration.

• 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: 50776389
• Report Number: 3004672275-2026-00290
• Device Sequence Number: 10682946
• Product Code: CAW
• UDI-Device Identifier: 00817131020162
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/15/2026

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?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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