MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3 OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the patient that, while riding in the car, she started to feel ill and her o2 levels allegedly dropped.The patient went to the hospital to seek medical attention.Inogen is currently pending the receipt of the medical records for this report.Inogen will write a supplemental filing with any additional information gathered.A failure investigation report was initiated to determine the cause of the alleged malfunction.The investigation concluded that the device was functioning as intended and no device malfunction occurred.It was also confirmed that the auto-pulse function on the device, intended to deliver oxygen at a fixed rate based on setting in the event that a breath is not detected, was working as intended.
Event or Problem Description
It was reported by the patient that, while riding in the car, she started to feel ill and her o2 levels allegedly dropped.When this occurred, her husband drove her to the hospital.
Additional Manufacturer Narrative
Inogen was unable to receive the device for investigation and therefore could not confirm the complaint.No further investigation will be conducted.

• Brand Name: INOGEN ONE G3 OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 326 bollay dr; goleta CA 93117
• MDR Report Key: 10053506
• Report Number: 3015238204-2020-00002
• Device Sequence Number: 11362840
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: 00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: IO-300
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR