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

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.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, 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 Key: 9934025
• Report Number: 2518422-2020-00847
• Device Sequence Number: 1
• Product Code: CAW
• 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 Received: 04/08/2020
• 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 Received: 05/26/2020
• 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