MAUDE Adverse Event Report: FLIGHT DENTAL SYSTEMS/ HR DENTAL PRODUCTS, INC. FLIGHT DENTAL SYSTEMS; DENTAL OPERATORY PACKAGE

Model Number A2-E

Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Information (3190)

Event Date 08/08/2015

Event Type  malfunction  

Event Description

Flight dental operatory package started smoking while in use with a pt in the chair.Fool smelting smoke rose to the ceiling from the unit and melted the cavitron receptacle.(b)(6)- on (b)(6) 2015, the flight dental chair's treatment tray/head started smoking while i was adjusting a pt's denture.The seated pt actually noticed the black, grayish smoke coming from the sides of the tray/head.The smoke had an awful smell and rose to the ceiling.The heat from the fire melted the black cavitron receptacle.The chair shut-down and would not function.

• Brand Name: FLIGHT DENTAL SYSTEMS
• Type of Device: DENTAL OPERATORY PACKAGE
• Manufacturer (Section D): FLIGHT DENTAL SYSTEMS/ HR DENTAL PRODUCTS, INC.; 21 kenview blvd, unit 9; brampton, on L6T 5 G7; CA L6T 5G7
• MDR Report Key: 5921499
• MDR Text Key: 53729457
• Report Number: MW5064480
• Device Sequence Number: 1
• Product Code: EBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2-E
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1