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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

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INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR Back to Search Results
Model Number 630
Device Problem Use of Device Problem
Event Date 04/11/2020
Event Type  Injury  
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 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.

 
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Brand NameINOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
Type of DeviceINOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
Manufacturer (Section D)
INOGEN, INC.
326 bollay dr.
goleta, tx
Manufacturer (Section G)
INOGEN, INC.
1225 commerce dr.
richardson, tx
Manufacturer Contact
laura lyons
1225 commerce dr.
richardson, tx  
7294119
MDR Report Key10053506
Report Number3015238204-2020-00002
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number630
Device Catalogue NumberIO-400
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/13/2020 Patient Sequence Number: 1
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