THE TS-10 INSTRUCTIONS FOR USE (IFU), CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL INFORMATION, STATES, "IN THE UNLIKELY EVENT THAT THE SYSTEM EMITS AN UNUSUAL ODOR OR SMOKE, IMMEDIATELY TURN OFF THE MAIN SWITCH AND UNPLUG THE POWER CABLE. THEN CONTACT YOUR SYSMEX SERVICE REPRESENTATIVE. CONTINUED USE OF THE SYSTEM IN SUCH CONDITIONS COULD RESULT IN FIRE, ELECTRICAL SHOCK OR PERSONAL INJURY." THE TS-10 WAS UNPLUGGED AFTER THE ODOR WAS OBSERVED. FUSES ARE LOCATED IN FUSE HOLDERS AT THE BACK OF THE SYSTEM BEHIND A METAL PLATE, NOT READILY ACCESSIBLE TO THE USER. FURTHERMORE, THE FUSE HOLDERS ARE MADE OF FLAME RESISTANT MATERIAL, REDUCING POTENTIAL FOR COMBUSTION. INVESTIGATION BY SYSMEX CORPORATION (B)(4) (S-CORP) IS IN PROCESS. THE SE REPLACED THE FUSE HOLDER TO RESOLVE THE ISSUE.
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Patient 1
A USER IN (B)(6) REPORTED A BURNING ODOR EMANATING FROM THE TUBE SORTER. A SERVICE ENGINEER (SE) WAS DISPATCHED THE NEXT DAY AND FOUND THE FUSE HOLDER WAS BURNT. NO SMOKE OR FIRE WAS OBSERVED. NO USER OR PATIENT HARM WAS INCURRED.
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Patient 1
SYSMEX CORPORATION (B)(4) (S-CORP) COMPLETED THE INVESTIGATION. THE INVESTIGATION DETERMINED INSUFFICIENT TIGHTENING OF THE FUSE HOLDER CAP DURING THE SUPPLIER ASSEMBLY PROCESS CAUSED THE EVENT. INSUFFICIENT CONTACT BETWEEN THE FUSE HOLDER CAP AND THE FUSE LED TO HEAT GENERATION CAUSING THE FUSE HOLDER TO BURN. S-CORP WAS ABLE TO REPRODUCE THE ISSUE. THE FUSE HOLDER IS MADE OF FLAME RESISTANT MATERIAL. FLAME RESISTANT MATERIALS ARE DESIGNED TO PREVENT COMBUSTION; HOWEVER, STILL HAVE THE POTENTIAL TO BURN. NO OTHER SYSMEX DEVICES USE THESE TYPES OF FUSES. NO USERS WERE INJURED OR OTHER AREAS OF THE DEVICE DAMAGED DUE TO THE BURNT FUSE HOLDER. S-CORP ISSUED A COUNTERMEASURE TO THE SUPPLIER TO INCREASE THE TORQUE AND CONFIRM THE CAP IS APPROPRIATELY TIGHTENED. AFTER CONFIRMATION, THE SUPPLIER WILL MARK THE CAP INDICATING THE CAP WAS TIGHTENED AND CONFIRMED.