MAUDE Adverse Event Report: INOGEN, INC. INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-401
Medical Device Problem Codes	Overheating of Device (1437); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Burn(s) (1757); Low Oxygen Saturation (2477)
Date of Event	04/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The unit received a reported system hot, which was not confirmed, diagnostic screen shows sieve warning due to high psa (14) and data log also shows multiple psa-14 and sieve warning.The internal 02 reading measured 89%, while the external 02 reading measured 87%.The issue was caused by low columns efficiency due to zeolite absorbed too much moisture.Housing top and lower was damaged issues caused by possibly drop the unit.And the unit has failed on sensor blocks due to tester transducer x1, x2 fails on repeat testing.
Event or Problem Description
It was reported that the patient's device got hot and shut down by itself while at church, and the patient's oxygen levels decreased.Patient stated the device got so hot it felt like it was burning their skin.As a result, the patient went home to their stationary oxygen unit.Replacement device has been received and no issues have been noted with the device.

• Brand Name: INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ROVE 4 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: 25259875
• Report Number: 3004672275-2026-00137
• Device Sequence Number: 12136459
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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-401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown