MAUDE Adverse Event Report: INOGEN INC. INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-501
Medical Device Problem Codes	No Flow (2991); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was returned for evaluation on 31-mar-2026.The unit was returned with a system error complaint, which was confirmed during testing.The fan was misaligned and contacting the accumulator likely due to high-impact incident, possibly from the unit being dropped.Also, high pressure caused by the muffler being filled with dust, which resulted in a blockage in the feed port and low sieve life (294), low internal (86.6%}, low external (87.9%).Furthermore, the psa cycle being high (14) is an indication that the zeolite is getting contaminated by moisture.Uip & lower housing were also replaced due to cosmetic damage.
Event or Problem Description
It was reported that the unit shuts down by itself.As a result, the patient was not receiving oxygen and had to dial emergency services.A replacement unit was sent to the patient.The inogen team attempted to contact the patient for further information three times with no response.

• 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: 24900116
• Report Number: 3004672275-2026-00099
• Device Sequence Number: 18312105
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• 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): 04/16/2026

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-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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: Life Threatening
• Patient Sex: Unknown