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

Model Number	IO-401
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The unit received a reported system error, confirmed with contaminated zeolite.Incoming internal 02 measured 75.S.% and external 02 measured 83.1 %, both below specification.The issue was identified as high psa (14) caused by zeolite contamination from moisture absorption.Uip and top housing replaced due to cosmetic damage.
Event or Problem Description
It was reported that the patient had to turn off their device multiple times as the device would get to hot, leaving the patient unable to breathe without oxygen.The patient had another portable oxygen concentrator for backup but did not have a stationary oxygen concentrator or oxygen tank.The patient has since received their replacement device and has no complications.

• 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: 25717874
• Report Number: 3004672275-2026-00187
• Device Sequence Number: 10598369
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/06/2026

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: 06/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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