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

Model Number	1020009
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
An everflo oxygen concentrator was returned to a third party service center for evaluation.There was no harm or injury reported.During the evaluation of the device at a third party service center, thermal damage to the power cord was observed.The device's power cord was replaced to address the issue.Product labeling states,"do not use the oxygen concentrator if either the plug or power cord is damaged.Do not use extension cords or electrical adapters.Keep the device at least 15 to 30 cm 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).".
Additional Manufacturer Narrative
The manufacturer previously reported the incorrect date as 12/28/2019.The correct date received by the manufacturer is 12/28/2018.

• 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: 8257841
• Report Number: 1040777-2019-00004
• Device Sequence Number: 16602679
• Product Code: CAW
• UDI-Device Identifier: 00606959032583
• UDI-Public: 00606959032583
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020009
• Device Catalogue Number: 1020009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1