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

Model Number	1020015
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator caught on fire and burnt.There was no report of patient harm or injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the device externally and found the patient tubing to have ignited and caused cosmetic damage to the device.The device had evidence of several areas of thermal damage that is consistent with an external source.An internal inspection of the device was completed by the manufacturer.The device has evidence of contamination of dust and dirt and odor of tar and nicotine.There was no report of thermal damage internally to the device.The device could not be tested to due to the damage to 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 the thermal damage was caused by an external source.

• Brand Name: EVERFLO QUIET
• 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: 15004775
• Report Number: 2518422-2022-03312
• Device Sequence Number: 1613968
• Product Code: CAW
• UDI-Device Identifier: 00606959032637
• UDI-Public: 00606959032637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 1020015
• Device Catalogue Number: 1020015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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: Male