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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INOGEN INC. INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
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INOGEN INC. INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR Back to Search Results
Catalog Number IO-300
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was smoking while using the inogen one g3 portable oxygen concentrator causing the reported fire.Inogen's engineering team completed the failure investigation report as attached within the emdr.It was found during the investigation that the inogen one g3 device was functional and did not have any evidence of internal heat damage indicating a device malfunction leading to the reported fire.It is noted in the failure investigation report that the inogen one g3 device had external burn marks and a strong cigarette odor.It should be noted that the fire department was dispatched to the patient's home and it is noted within the fire report that the patient reported smoking while on supplemental oxygen causing the incident.Inogen warms the patient against smoking while using the device within the user manual however, in the event of smoking while using the device, there is a potential risk fire which can result in serious injury or death.
 
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Brand Name
INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
Type of Device
INOGEN ONE G3
Manufacturer (Section D)
INOGEN INC.
1225 commerce drive
richardson TX 75081
Manufacturer Contact
mara korsunsky
326 bollay drive
goleta, CA 93117
8055620629
MDR Report Key8947843
MDR Text Key156081383
Report Number3015238204-2019-34567
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K032818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberIO-300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Initial Date Manufacturer Received 07/30/2019
Initial Date FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
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