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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: L & R MFG CO. QUANTREX; ULTRASONIC WASHER

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L & R MFG CO. QUANTREX; ULTRASONIC WASHER Back to Search Results
Model Number Q360H
Device Problems Fire (1245); Overheating of Device (1437); Smoking (1585)
Patient Problem No Information (3190)
Event Date 07/02/2018
Event Type  malfunction  
Event Description
Dental tech using the machine plugged the unit in and started to note a funny smell and noticed smoke coming from the side of the unit.The piece of equipment was reported to the medical maintenance department where in house technicians impounded the unit and verified the cause to a transducer which seemed to overheat and catch fire.
 
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Brand Name
QUANTREX
Type of Device
ULTRASONIC WASHER
Manufacturer (Section D)
L & R MFG CO.
kearny NJ
MDR Report Key7664537
MDR Text Key113257540
Report NumberMW5078252
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberQ360H
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/05/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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