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

Model Number	1039370
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
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 submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator alleging thermal damage to the power cord.There was no report of patient harm or injury.The power cord was not returned to the manufacturer for evaluation.The manufacturer was provided photographs of the power cord.The manufacturer reviewed the photographs and determined the power cord had physical damage closest to the entrance into the enclosure of the device and on the power cord itself.The power cord had two openings that separated.The device has been constrained against a flat surface and the continuous bending has fatigued the wires to the point of failure.Product labeling states,"for proper operation, your concentrator requires unobstructed ventilation.The ventilation ports are located at the rear base of the device and at the side air inlet filter.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)." do not use the oxygen concentrator if either the plug or power cord is damaged.Do not use extension cords or electrical adapters." the manufacturer concludes the damage to the power cord was caused by physical damage.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13690964
• Report Number: 2518422-2022-09184
• Device Sequence Number: 17421139
• Product Code: CAW
• UDI-Device Identifier: 00606959020436
• UDI-Public: 00606959020436
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 1039370
• Device Catalogue Number: 1039370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown