MAUDE Adverse Event Report: PHILIPS RESPIRONICS MILLENIUM; OXYGEN CONCENTRATOR

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

Patient Problem Burn(s) (1757)

Event Date 05/16/2017

Event Type  Injury  

Event Description

Home oxygen pt was smoking with oxygen on and ignited a fire in her apartment.Pt received burns and is hospitalized.Set up on oxygen on (b)(6) 2011.Concentrator switch out was completed on (b)(6) 2017.

• Brand Name: MILLENIUM
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 6622134
• MDR Text Key: 76998950
• Report Number: MW5070251
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SET UP ON OXYGEN
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR