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

Model Number	1020012
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient received burns to their airways while using an everflo oxygen concentrator.The device is not being returned to the manufacturer's service center.The device is currently still being used by the patient.Photographs provided by the durable medical equipment (dme) supplier was reviewed by the manufacturer.It appears the burns were from an external source near the nasal cannula.The device has no evidence of thermal damage to the enclosure of the device.Product labeling states,"oxygen vigorously accelerates combustion and should be kept away from heat or open flame.Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use." the manufacturer concludes there was no evidence of thermal damage to the device and that the burns suffered by the patient was from an external source.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11245179
• Report Number: 2518422-2021-00176
• Device Sequence Number: 14367158
• Product Code: CAW
• UDI-Device Identifier: 00606959032606
• UDI-Public: 00606959032606
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020012
• Device Catalogue Number: 1020012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other