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

Model Number 1020006

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

Patient Problem Burn(s) (1757)

Event Date 04/14/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient lit a cigarette while using an everflo oxygen concentrator.The nasal cannula caught on fire and the patient reportedly received burns to his nose but did not seek medical attention.The device was evaluated by a third party service center.The third party service center confirmed there was no thermal damage to the device or any malfunction that would cause a thermal event.Product labeling states,"do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.The manufacturer concludes the event was due to user error.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville 15146 ; 7243875658
• MDR Report Key: 4762610
• MDR Text Key: 5780741
• Report Number: 1040777-2015-00024
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 04/14/2015

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
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other