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U.S. Department of Health and Human Services

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

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PHILIPS-RESPIRONICS INC. OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number EVERFLO
Device Problem Fire (1245)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 01/15/2013
Event Type  Injury  
Event Description
Patient was smoking a caught b/u on fire.She had to be sent to the hospital for 3rd degree burns to her face.She at first said it was the cord that caught on file.But after further speaking to her she admitted that she had been smoking.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
OXYGEN CONCENTRATOR
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS-RESPIRONICS INC.
MDR Report Key17516573
MDR Text Key321037477
Report NumberMW5123522
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberEVERFLO
Patient Sequence Number1
Patient Age70 YR
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