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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 Invalid Sensing
Event Date 05/14/2012
Event Type  Injury  
Event Description

The manufacturer received information alleging a patient was smoking while using an everflo oxygen concentrator and suffered burns. It is unknown what type of medical intervention was required for the patient.

 
Manufacturer Narrative

The manufacturer received limited information on this reported event. The durable medical equipment supplier (dme) reported to the manufacturer that the device is currently on another patient without further incidents reported. Several attempts have been made by the manufacturer to obtain more information from the dme and were unsuccessful. The manufacturer believes they will be unable to gather additional information. The manufacturer is submitting a final report at this time. If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

 
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Brand NameEVERFLO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
kennesaw GA
Manufacturer Contact
don mcandrews
1740 golden mile highway
monroeville , PA 15146
7243873965
MDR Report Key3975689
Report Number1040777-2014-00017
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1020000
Device Catalogue Number1020000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2009
Is The Device Single Use? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/09/2014 Patient Sequence Number: 1
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