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

Model Number 1020000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/12/2019

Event Type  Death  

Event Description

The manufacturer received information alleging a patient was smoking a cigarette while using the everflo oxygen concentrator.The cigarette ignited a fire and the patient was taken to the hospital where she later expired.The device has yet to be returned to the manufacturer's service center for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient was allegedly smoking a cigarette while using the everflo oxygen concentrator.The patient expired.The device is not returning to the manufacturer for evaluation.The reporter of the event stated the device was not being released by the family and believes the device was discarded.Product labeling states, "do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.Oxygen vigorously accelerates combustion and should be kept away from heat or open flame.Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.".

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8846349
• MDR Text Key: 152797889
• Report Number: 1040777-2019-00034
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR