MAUDE Adverse Event Report: Inogen, Inc. Inogen Rove 6 Portable Oxygen Concentrator

Model Number	IO-501
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit received a complaint of a burning smell; the complaint was confirmed, melted outside upper housing and lower housing caused by fire sources.The unit was found to have low oxygen that is caused by column contaminated due to absorbing too much moisture.The muffler was filled with dust, which contributed to the blockage.
Event or Problem Description
It was reported that the patient's device charger burned and damaged the device while it was being charged.A burning smell was observed due to the event.It was noted that there was minor property damage, but there were no reported injuries or negative impact to patient's health due to the event.This report will be on the patient's device.

• Brand Name: Inogen Rove 6 Portable Oxygen Concentrator
• Common Device Name: Inogen Rove 6 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: 50229606
• Report Number: 3004672275-2026-00248
• Device Sequence Number: 16016580
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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
• Patient Sex: Unknown