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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIR TECHNIQUES INC. SCANX CLASSIC ILE
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AIR TECHNIQUES INC. SCANX CLASSIC ILE Back to Search Results
Model Number B7200
Device Problems Electrical /Electronic Property Problem (1198); Arcing (2583); Lack of Maintenance Documentation or Guidelines (2971)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
The device was returned without the power supply cord so a full evaluation could not be conducted.The power supply cord cannot be located.
 
Event Description
The hygenist at the dental facility noticed in the afternoon that the external power supply cord on the back of the scanx unit was smoking.Unit was not being used at that time.
 
Event Description
The hygienist at the dental facility noticed in the afternoon that the external power supply cord on the back of the scanx unit was smoking.Unit was not being used at that time.No one was hurt.
 
Manufacturer Narrative
A device was sent for further evaluation to determine the root cause.
 
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Brand Name
SCANX CLASSIC ILE
Type of Device
SCANX CLASSIC
Manufacturer (Section D)
AIR TECHNIQUES INC.
1295 walt whitman road
melville NY 11747
MDR Report Key7554982
MDR Text Key109758315
Report Number2428225-2018-00003
Device Sequence Number1
Product Code MUH
Combination Product (y/n)N
PMA/PMN Number
K013893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberB7200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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