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

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.

• Brand Name: QUANTREX
• Type of Device: ULTRASONIC WASHER
• Manufacturer (Section D): L & R MFG CO.; kearny NJ
• MDR Report Key: 7664537
• MDR Text Key: 113257540
• Report Number: MW5078252
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: Q360H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1