The ts-10 instructions for use warn the user in chapter 2 - safety information, section 2.1 - general information: "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 fuse holder is located in the control device and 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.
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Sysmex corporation japan (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.
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