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

Model Number	1020008
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator had thermal damage to the power cord.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.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator allegedly had evidence of thermal damage to the power cord.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.The manufacturer found 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 (such as a closet)." "do not use the oxygen concentrator if either the plug or power cord is damaged.".
Additional Manufacturer Narrative
The manufacturer previously reported that the device was not returned to the manufacturer incorrectly.The device was returned to the manufacturer for evaluation.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8069176
• Report Number: 1040777-2018-00047
• Device Sequence Number: 2153860
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: 00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 01/23/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/18/2019; 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1