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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 1020001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Evaluation conclusion = device has been scrapped per the customer's request.

 
Event Description

The manufacturer received information alleging an everflo oxygen concentrator was involved in a house fire. There was no report of patient harm or injury. The device was returned to the manufacturer for evaluation. The manufacturer confirmed there was no evidence of thermal damage internally to the device. The device had evidence of thermal damage to the outer and rear cabinets, indicating the source of the fire was external to the device. The reporting of the event confirmed the family were heavy smokers. Product labeling for the everflo oxygen concentrator instructs the user, "oxygen vigorously accelerates combustion and should be kept away from heat or open flame. Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use. " the manufacturer concludes the fire originated external to the device and the device did not cause the fire.

 
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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.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
wilfredo alvarez
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key5630938
MDR Text Key44388297
Report Number1040777-2016-00015
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 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 04/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1020001
Device Catalogue Number1020001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/20/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/20/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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