MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An internal investigation of the production records was initiated to determine the cause of the malfunction.Investigation revealed that there was no device malfunction, and the concentrator functioned as intended.Inogen will write a supplemental filing with any additional information gathered.
Event or Problem Description
It was reported the patient experienced a house fire.Reportedly, the patient plugged the portable oxygen concentrator into a power strip.As a result, the patient was sent to the hospital for smoke in her lungs.In turn, the patient was stable at home.

• Brand Name: INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd.; plano TX 75074
• Manufacturer Contact: falon whitfield ; 600 shiloh rd.; plano, TX 75074 ; 9726165673
• MDR Report Key: 13685059
• Report Number: 3015238204-2021-00040
• Device Sequence Number: 13929619
• Product Code: CAW
• UDI-Device Identifier: 00817131020056
• UDI-Public: 00817131020056
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2022

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-300
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female