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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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PHILIPS RESPIRONICS INC. EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/26/2020
Event Type  Injury  
Event Description

The manufacturer received a voluntary medwatch, (b)(4), that alleged a patient was smoking while an oxygen concentrator was in use. The oxygen tubing caught on fire. The patient sustained 2nd degree burns to their thigh and refused medical treatment. The investigation is still ongoing. A follow up report will be submitted when the manufacturer has completed the investigation.

 
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Brand NameEVERFLO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
1001 murry ridge lane
murrysville, pa
Manufacturer (Section G)
PHILIPS RESPIRONICS INC.
1001 murry ridge lane
murrysville, pa
Manufacturer Contact
adam price
1001 murry ridge lane
murrysville, pa  
MDR Report Key9934025
Report Number2518422-2020-00847
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/08/2020 Patient Sequence Number: 1
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