3M TRUE DEFINITION SCANNER

Additional Manufacturer Narrative

APPROPRIATE ELECTRICAL SAFETY MEASURES (ISOLATION TRANSFORMER) ARE PRESENT IN THE TRUE DEFINITION SCANNER SYSTEM. THE 3M TRUE DEFINITION SCANNER INSTRUCTIONS FOR USE DOES CONTAIN THE WARNING, '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.'

Description of Event or Problem

DURING A SCANNING PROCEDURE USING A 3M TRUE DEFINITION SCANNER, A PATIENT EXPERIENCED A SHOCK AND PAIN INSIDE THE MOUTH. IT WAS CONFIRMED THAT THE POWER OUTLET, WHERE THE SCANNER WAS CONNECTED AT THE TIME THE INCIDENT OCCURRED, WAS NOT PROPERLY GROUNDED. AFTER THE SCANNER WAS PLUGGED INTO THE POWER OUTLET WHERE THE GROUND WAS PROVEN TO BE WIRED AND FUNCTIONING PROPERLY, NO MORE SHOCKS OCCURRED. THE DENTIST WAS ADVISED OF THE INVESTIGATION FINDINGS AND AGREED THAT THE INCIDENT WAS CAUSED BY THE FAULTY POWER OUTLET AT THE OFFICE; AN ELECTRICIAN WAS CALLED AND FIXED ALL POWER OUTLETS IN THE OFFICE.