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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 Concentrator (558); Fire (1245); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2016
Event Type  Injury  
Event Description

The manufacturer received information alleging an everflo oxygen concentrator was not working properly and caught on fire. There was no report of patient harm or injury. The device has yet to be evaluated. A follow up report will be filed when the manufacturer has completed the investigation.

 
Manufacturer Narrative

The manufacturer previously reported an everflo that allegedly was not working properly and caught on fire. The device was returned to the manufacturer's service center. The manufacturer determined the fire originated external to the device. There was no evidence of a malfunction that indicated the fire was a result of a defect or internal problem. The device operated to design specifications. The exterior of the device showed evidence of thermal damage indicating the fire followed the cannula and stopped near the oxygen outlet. Product labeling states, "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 was caused by an external source. 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
175 chastain meadows court
kennesaw GA 30144
Manufacturer Contact
wilfredo alvarez
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key5679960
MDR Text Key45939061
Report Number1040777-2016-00017
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 DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 05/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1020000
Device Catalogue Number1020000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/09/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2014
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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