LEICA DM 2000

Description of Event or Problem

TECHNICIAN TOUCHED FOCUS KNOB WITH ONE HAND WHILE HER OTHER HAND WAS ON THE CONDENSER AND ALLEGEDLY RECEIVED A SHOCK. THE TECHNICIAN REPORTEDLY FELT BURNING AND NUMBNESS IN HER HAND AND WAS GOING TO SEE A NEUROLOGIST. IT IS UNKNOWN IF THE TECHNICIAN VISITED A NEUROLOGIST AND ANY MEDICAL INTERVENTION WAS REQUIRED. THE MICROSCOPE WAS PLUGGED INTO A LEICA LIGHT SOURCE. INVESTIGATION SHOWED THAT THE MICROSCOPE ORIGINALLY WAS NOT CONNECTED TO THE MAINS SUPPLY AS IT IS USED ONLY FOR REFLECTED LIGHT FLUORESCENCE WITH EXTERNAL LIGHT SOURCE. IT WAS DECIDED TO PLUG IT IN FOR PROPER GROUNDING. BIOMEDICAL DEPARTMENT PERSONNEL ONSITE TESTED THE UNIT AND CONCLUDED A LEAKAGE CURRENT AT .75MA WHICH IS WITHIN LIMITS OF ACCEPTANCE. EVENT DESCRIPTION INDICATES THAT THE DEVICE DID NOT CONTRIBUTE TO SERIOUS INJURY OR DEATH AND FURTHER INVESTIGATION WILL BE CONDUCTED IN RESPECT TO POTENTIAL BUILD UP OF STATIC SHOCK.

Additional Manufacturer Narrative

DURING INTERVIEWS CONDUCTED WITH THE CUSTOMER DURING THE INVESTIGATION, IT WAS COMMUNICATED THAT THE HOSPITAL'S BIOMEDICAL ENGINEERS HAD TESTED THE LEAKAGE FROM THE INSTRUMENTATION AND IT MEETS THE CSA ELECTRICAL STANDARDS. THEY SAID THE LEAKAGE WAS NOT ENOUGH TO CAUSE A SHOCK. ADDITIONALLY, THE SAFETY DOCUMENTATION IN THE OPERATING MANUAL STATUS THAT ANY INTERRUPTION OF THE GROUND WIRE INSIDE OR OUTSIDE OF THE DEVICE, OR RELEASE OF THE GROUND WIRE CONNECTION CAN CAUSE THE DEVICE TO BECOME HAZARDOUS. THE STAND WAS NOT PLUGGED IN AT THE TIME OF THE SHOCK AND, THEREFORE, IT WAS NOT GROUNDED. THE BIOMEDICAL ENGINEERS HAVE NOW CONNECTED AN ISOLATION TRANSFORMER INTO THE ELECTRICAL WALL OUTLET TO PLUG THE MICROSCOPE POWER CABLE INTO IT. BECAUSE LEICA TECHNICAL SERVICE PERSONNEL AND THEIR BIOMEDICAL ENGINEERS COULD NOT FIND A REASON WHY THE LAB TECHNICIAN RECEIVED A SHOCK, THE MICROSCOPE AND SYSTEM ARE BEING SENT FROM THE CUSTOMER TO ANOTHER COUNTRY'S MFR TO CONDUCT FURTHER TESTING. THEY HAVE BEEN PROVIDED A REPLACEMENT IN THE INTERIM. THEIR EQUIPMENT WILL BE RETURNED TO SERVICE AT THE HOSPITAL FOLLOWING THE MANUFACTURER'S INVESTIGATION. COMPARABLE SYSTEM EVALUATED AT FACTORY: NO PRODUCT FAILURES DETECTED.