MAUDE Adverse Event Report: Inogen, Inc. Inogen One G3 High Flow Portable Oxygen Concentrator

Model Number	IO-300
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Charge (1085)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was not charging while plugged in at a court house and the device battery was also not lasting as long as expected.As a result, the device ran out of power and the patient passed out due to being without oxygen.The patient was taken to the hospital and put on life support.The patient has since been released and received their replacement device.
Additional Manufacturer Narrative
B3: date of event is estimated.There is no confirmation for the return reason of battery error.Zeolite is found contaminated which possibly caused when it absorbs the moisture.

• Brand Name: Inogen One G3 High Flow Portable Oxygen Concentrator
• Common Device Name: Inogen One G3 High Flow 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: 50046428
• Report Number: 3004672275-2026-00217
• Device Sequence Number: 21202631
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/27/2026

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-300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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; Life Threatening
• Patient Sex: Unknown