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

Model Number 1020006

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator had sparks and flames coming from the power cord during use.There was no report of patient harm or injury.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported that an everflo oxygen concentrator alleged had sparks and flames coming from the power cord during use.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The device has evidence of thermal damage to the power cord.The power cord was observed to have damage consistent with the application of excessive force by the end user.It appears the device was placed too close to a hard surface.This caused the power cord to bend, creating weakness in the power cord.Product labeling for the everflo oxygen concentrator states, "keep the device at least 15-30cm away from walls, furniture, and especially curtains that could impede adequate airflow to the device.Do not place the concentrator in a small closed space (suchas a closet)." "do not use the oxygen concentrator if either the plug or power cord is damaged.".

• 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: 8692004
• MDR Text Key: 147756722
• Report Number: 1040777-2019-00030
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1