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

Model Number 1020000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 06/11/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging an oxygen concentrator sparked while in patient use.The patient sustained burns to their nose and mouth.The patient refused to go to the hospital for treatment.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an oxygen concentrator sparked while in patient use.The patient sustained burns to their nose and mouth.The patient refused medical treatment.Corrections to section b2 and h1.Below is the correct information.Section b2: other serious (important medical events) section h1: serious injury.

Manufacturer Narrative

The manufacturer previously reported an oxygen concentrator allegedly sparked while in patient use.The patient sustained burns to their nose and mouth.The patient refused to go to the hospital for treatment.The device is not returning to the manufacturer for evaluation.The reporting durable medical equipment (dme) supplier tested the device and found the device to operate properly.The device was placed back into service and is now being used by another patient.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
• MDR Report Key: 10246030
• MDR Text Key: 197978098
• Report Number: 2518422-2020-01541
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/23/2020; 07/27/2020
• Supplement Dates FDA Received: 07/09/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other