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

Model Number 1020010

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 10/21/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator was being used near a candle and caught fire.The patient suffered burns and was hospitalized.There was no report of device malfunction that caused the event.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.".

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: 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: adam price ; 1001 murry ridge lane; murrysville, PA 15668
• MDR Report Key: 10749942
• MDR Text Key: 213630421
• Report Number: 2518422-2020-02546
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization