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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
Model Number 1020000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 09/09/2019
Event Type  Malfunction  
Event Description

The manufacturer received information alleging an everflo oxygen concentrator was involved in a house fire. The tenant of the house received burns. It is unknown if medical attention was required. The investigation is still ongoing. 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)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068 3724
Manufacturer (Section G)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key9081687
MDR Text Key158981806
Report Number1040777-2019-00042
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1020000
Device Catalogue Number1020000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
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: 09/18/2019 Patient Sequence Number: 1
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