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

Model Number A2-F

Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Multiple malfunctions of flight dental operatory package listed: chair has flooded twice; air/water tip leaks throughout dental procedures; cavitron/ultrasonic built in handpiece overheats making it impossible to complete a cleaning procedure; unit does not maintain constant water pressure during procedures; moving chair positioning causes loud noises.

• 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: 5924586
• MDR Text Key: 54029472
• Report Number: MW5064502
• Device Sequence Number: 1
• Product Code: EIA
• 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-F
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1