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

Model Number	1020016
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 evaluated by the manufacturer's service center.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 having thermal damage to the power cord.There was no report of patient harm or injury.The device was returned to a third party service center for evaluation.During the evaluation of the device, the manufacturer confirmed the customer's complaint.The power cord was replaced to address the issue.Product labeling states," 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).".

• 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: 7365715
• Report Number: 1040777-2018-00015
• Device Sequence Number: 19267693
• Product Code: CAW
• UDI-Device Identifier: 00606959032644
• UDI-Public: 00606959032644
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: 1020016
• Device Catalogue Number: 1020016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/3018
• Supplement Date Received by Manufacturer: 04/28/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1