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

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal investigation was initiated to determine the cause of the malfunction.Inogen's investigation of the device is complete.This unit is running normally and as designed.Inogen will write a supplemental filing with any additional information gathered.
Event or Problem Description
It was reported the patient experienced no oxygen output from the device.In turn, the patient switched units and later experienced "system hot error message." as a result, the patient was taken to the hospital and admitted.
Additional Manufacturer Narrative
Additional information: g1.Additonal information gathered via patient, mentioned inogen one portable concentrator at no time stopped working, as there was no device malfunction.Reportedly, patient was not wearing her oxygen for an unknown reason when the event happened.Therefore, the event was unrelated to the unit.

• Brand Name: INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 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: 14355550
• Report Number: 3015238204-2022-00049
• Device Sequence Number: 4958774
• Product Code: CAW
• UDI-Device Identifier: 00817131020032
• UDI-Public: 00817131020032
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 840
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2013
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Unknown