3M TRUE DEFINITION SCANNER

Additional Manufacturer Narrative

A SERVICE TECHNICIAN COMPLETED AN ELECTRICAL ASSESSMENT AT THE REPORTING OFFICE ON 01/19/17. THE ANALYSIS FOUND THAT THE SYSTEM WAS IN OPERATION WITHOUT THE FACTORY SUPPLIED ISOLATION TRANSFORMER AND POWER SUPPLY. IN ADDITION, THE DEVICE WAS USED WITH A 2-PIN POWER CABLE INSTEAD OF A IEC CERTIFIED APPROVED POWER SUPPLY CORD. IT WAS ALSO NOTED THAT THE SUBJECT IS VERY SENSITIVE AND MAY HAVE BROKEN FRONT TEETH AND MINOR ENAMEL THICKNESS PROBLEMS. APPROPRIATE ELECTRICAL SAFETY MEASURES (ISOLATION TRANSFORMER) ARE PRESENT IN THE TRUE DEFINITION SCANNER, MOBILE EDITION. THE INSTRUCTIONS FOR USE CONTAINS THE WARNINGS: 'TO REDUCE THE RISKS ASSOCIATED WITH HAZARDOUS VOLTAGE AND FIRE - USE ONLY A PROPERLY GROUNDED POWER OUTLET; DO NOT USE EXTENSION CORDS OR MULTIPLE PORTABLE POWER SOCKET OUTLETS, AND " USE THE ISOLATION TRANSFORMER AND POWER ADAPTER PROVIDED BY 3M TO POWER AND RECHARGE THE TABLET." ELECTRICAL SAFETY TESTING ON THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION WAS PERFORMED BY THE SERVICE TECHNICIAN ACCORDING TO ELECTRICAL SAFETY STANDARD VDE0751 ((B)(4)). THE DEVICE MET ALL SPECIFICATIONS WHEN USED WITH THE PROVIDED ISOLATION TRANSFORMER AND POWER SUPPLY.

Description of Event or Problem

ON (B)(6) 2017, 3M WAS NOTIFIED THAT TWO DENTAL EMPLOYEES EXPERIENCED SOMETHING LIKE AN ELECTRICAL IMPULSE DURING SCANNING OF THE FRONT TEETH USING THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION. THIS REPORT IS BEING SUBMITTED FOR THE FIRST EMPLOYEE. NO INJURY OCCURED AS A RESULT OF THIS EVENT.