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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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RESPIRONICS INC EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020000
Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 04/29/2016
Event Type  Death  
Event Description

The manufacturer received information alleging an everflo oxygen concentrator caught on fire while in use, the patient expired. The device was evaluated by the manufacturer and a third party investigator. A cigarette or a hot object came in contact with the cannula and ignited the cannula. The cannula burned back to the concentrator and caught the carpet, sofa and surrounding area on fire. The advanced fire melted the enclosure of the concentrator. It was determined by the third party investigator the concentrator did not cause the fire. The user manual of the everflo oxygen concentrator states the following,"oxygen vigorously accelerates combustion and should be kept away from heat or open flame. Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use. " the manufacturer concludes the fire was caused by an external source other than the oxygen concentrator.

 
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Brand NameEVERFLO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS INC
175 chastain meadows court
kennesaw GA 30144
Manufacturer (Section G)
RESPIRONICS INC
175 chastain meadows court
kennesaw GA 30144
Manufacturer Contact
wilfredo alvarez
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key5679963
MDR Text Key45938021
Report Number1040777-2016-00016
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
PMA/PMN NumberK061261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1020000
Device Catalogue Number1020000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/25/2016 Patient Sequence Number: 1
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