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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
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.
 
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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 Key5921480
MDR Text Key53724940
Report NumberMW5064479
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 an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2
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? No
Type of Device Usage

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