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U.S. Department of Health and Human Services

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

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INOGEN INC. INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 OXYGEN CONCENTRATOR Back to Search Results
Model Number IO-300
Device Problem Use of Device Problem
Event Date 07/03/2019
Event Type  Injury  
Event Description

A patient of inogen's customer indicated that they were blowing out a candle while on the inogen one g3 portable oxygen concentrator which caused the device to catch on fire. Inogen facilitated the return of the device to the engineering team which completed the failure investigation report. The failure investigation report concluded that there is evidence of an external flame which initiated the reported fire. Furthermore, the investigation found that there was not any evidence that a device malfunction occurred and the unit was found to be functional at the time of the failure investigation report. Additional feedback from inogen's engineering team included that there was evidence that the fire started externally on the front of the carry bag and burned inward but was extinguished prior to affecting any of the internal components. Inogen's device (g3 portable oxygen concentrator) is designed to prevent a fire from propagating back into the concentrator from the cannulas. This was confirmed in the failure investigation report as there was not any evidence that the fire propagated through the device affecting the internal components. It should be noted that inogen instructs the patient against using the device within 10 feet of an open flame via the user manual.

 
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Brand NameINOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
Type of DeviceINOGEN ONE G3 OXYGEN CONCENTRATOR
Manufacturer (Section D)
INOGEN INC.
1225 commerce drive
richardson TX 75088
Manufacturer Contact
mara korsunsky
326 bollay drive
goleta , CA 93117
8055620629
MDR Report Key9153602
Report Number3015238204-2019-56789
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberIO-300
Device Catalogue NumberIO-300
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/26/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/03/2019 Patient Sequence Number: 1
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