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U.S. Department of Health and Human Services

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

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FLIGHT DENTAL SYSTEMS/ HR DENTAL PRODUCTS, INC. FLIGHT DENTAL SYSTEMS DENTAL OPERATORY PACKAGE Back to Search Results
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.
 
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Brand NameFLIGHT DENTAL SYSTEMS
Type of DeviceDENTAL 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 Key5921499
MDR Text Key53729457
Report NumberMW5064480
Device Sequence Number1
Product Code EBF
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/31/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2-E
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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