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

Model Number 1020014

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 12/07/2014

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient received burns to the face while using an everflo oxygen concentrator.Allegedly, the patient was smoking while using the oxygen concentrator.The patient was admitted to the hospital.The device has yet to be returned to the manufacturer evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer initially reported a patient was allegedly smoking while using the oxygen concentrator.The patient received burns to their face and was admitted to the hospital.The manufacturer received information from the reporting facility stating the oxygen concentrator was not involved in the fire.The fire originated in the living room of the patient's house.The concentrator was located in the bedroom.The patient escaped through the livingroom where the nasal cannula caught on fire, causing the third degree burns to the patient's face.The reporting facility confirms the device is still functional and there was no evidence of damage to the device.The device is in possession of the reporting facility and will not be released until their investigation is complete.The manufacturer concludes the device was not in the area of the fire, therefore could not be the cause of the fire.The device is operational and has no evidence of thermal damage.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: EVERFLO Q 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 ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 4383742
• MDR Text Key: 15321872
• Report Number: 1040777-2014-00035
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

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: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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): Hospitalization
• Patient Age: 62 YR