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

Model Number A2

Device Problems Fire (1245); Melted (1385); Smoking (1585)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Multiple malfunctions of flight dental operatory package listed below: on (b)(6) 2014 smoke and fire from wires connected to scaler while treating a pt.Chair was repaired.On (b)(6) 2015, smoke, fire, melted wires from scaler while treating a pt.Chair was repaired again.In (b)(6) 2015, smoke, melted scaler wand while treating a pt.After multiple repairs, the chair continued to malfunction and was removed from service due to potential hazards to pts and staff.See scanned page.

• 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: 5921480
• MDR Text Key: 53724940
• Report Number: MW5064479
• 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

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1