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

Model Number	IO-401
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 patient's daughter called inogen to report that the patient's device rove4 was not delivering oxygen to the patient.Per the daughter she stated patient was in distrees and she had to take the patient to the hospital to receive oxygen.The patient recieved oxygen, the daughter stated she was currently in a rehab recovering.
Additional Manufacturer Narrative
The unit was received for investigation on june 30, 2025.The unit was received with an oxygen error, and the complaint was confirmed through the data log, which also indicated contamination of the zeolite.The high psa 16 suggests that the zeolite was being compromised by moisture, leading to high column pressure, and decreased internal and external performance.Additionally, the housing was replaced due to cosmetic damage, and the compressor was found to be noisy because of damaged seals.The unit was repaired and the patient received a replacement unit.

• 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: 22385338
• Report Number: 3004672275-2025-00092
• Device Sequence Number: 7138732
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• 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
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Patient Sex: Unknown