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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 1039364
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 12/08/2015
Event Type  Injury  
Event Description

The manufacturer received information that a patient was smoking a cigarette while using an everflo oxygen concentrator. The patient received third degree burns to her face, trachea and lungs. The patient was resuscitated and placed on a ventilator. The patient was in hospice care at the time of the event. Product labeling states,"do not smoke, allow others to smoke or have open flames near the concentrator when it is in use. The manufacturer concludes the event was due to user error.

 
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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 Key5348039
MDR Text Key35174097
Report Number1040777-2016-00001
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1039364
Device Catalogue Number1039364
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/22/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/02/2015
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: 01/06/2016 Patient Sequence Number: 1
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