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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/24/2019
Event Type  Death  
Event Description

The manufacturer received information alleging a patient was smoking while using an oxygen concentrator. The patient and the oxygen concentrator caught on fire. The patient expired. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be submitted when the manufacturer has completed the investigation.

 
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Brand NameEVERFLO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer (Section G)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer Contact
adam price
1001 murry ridge lane
murrysville, PA 15668
7243349303
MDR Report Key9451502
MDR Text Key170270217
Report Number1040777-2019-00050
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1020000
Device Catalogue Number1020000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2015
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: 12/11/2019 Patient Sequence Number: 1
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