MAUDE Adverse Event Report: PHILIPS-RESPIRONICS EVERFLO; GENERATOR, OXYGEN, PORTABLE

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2014

Event Type  malfunction  

Event Description

Patient states she was smoking her cigarette while using her home based oxygen unit and a spark flew down and hit the oxygen tubing.This sparked a fire.She was taken to the hospital and given temporary tanks.Her house was pretty much a complete loss in addition to all our equipment.The stationary oxygen concentrator is manufactured by philips-respironics, everflo model, serial number (b)(6).This device is not manufactured by inogen inc.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EVERFLO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS-RESPIRONICS
• MDR Report Key: 17516417
• MDR Text Key: 321037719
• Report Number: MW5123366
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR