MAUDE Adverse Event Report: INOGEN,INC. INOGEN AT HOME OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Codes	Failure to Power Up (1476); No Flow (2991)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient has received a replacement unit 6 days after the event.A return of the malfunctioning unit has been initiated.Once the unit has been received an investigation will be conducted and a follow up will be submitted if required.
Event or Problem Description
According to the patient, both the stationary and portable oxygen concentrators were both malfunctioning while the patient was home.The patient had no source of oxygen including any back up or alternative oxygen supplies.The portable had no air flow and the stationary would shut off and would not stay on.So, the patient's daughter proceeded to call 911 and the patient went to the hospital.The patient was in the hospital for one week and a half.The patients daughter believes that due to the low oxygen, her mother had a stroke.The hospital proceeded with breathing treatment and oxygen.The patient is now home and doing okay.

• Brand Name: INOGEN AT HOME OXYGEN CONCENTRATOR
• Common Device Name: INOGEN AT HOME OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN,INC.; 600 shiloh rd.; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 19730549
• Report Number: 3004672275-2024-00035
• Device Sequence Number: 18150964
• Product Code: CAW
• UDI-Device Identifier: 00817131020131
• UDI-Public: (01)00817131020131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• 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): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: GS-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2015
• 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; Other; Required Intervention
• Patient Sex: Unknown