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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 1020006
Device Problem Electrical Shorting
Event Date 05/14/2019
Event Type  Malfunction  
Event Description

The manufacturer received information alleging an everflo oxygen concentrator had sparks and flames coming from the power cord during use. There was no report of patient harm or injury. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed 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
312 alvin drive
new kensington , PA 15068
7243349303
MDR Report Key8692004
Report Number1040777-2019-00030
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1020006
Device Catalogue Number1020006
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/15/2010
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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