Model Number XN-10 |
Device Problems
Thermal Decomposition of Device (1071); Charred (1086); Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The pcb is being sent to the manufacturer for further investigation to determine the root cause of the event.Any incident with excessive heat has the potential to cause user harm.The pcb is made of flame resistant materials and covered with a metal shield, but excessive heat from the event poses a risk of inhalation of smoke and/or harmful vapors from melted materials.The pcb is not accessible to the user, and is grounded, reducing the potential for harm due to shock.
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Event Description
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The user reported a burning odor coming from the back of the analyzer, and powered off the analyzer.A sysmex field service engineer (fse) arrived on site, and found the wiring cord and printed circuit board (pcb) were burnt.
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Manufacturer Narrative
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Sysmex corporation (b)(4) (s-corp) completed the investigation of the printed circuit board (pcb) and wiring cord.S-corp discovered two pins on pcb no.30001 were broken causing a short circuit.It is likely the pcb and wiring cord burned as a result of the short circuit.It is unknown how the pins became broken.This issue was determined to be an isolated event.There was no systemic deficiency identified, as no similar issue was reported.No further corrective action will be taken.
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Search Alerts/Recalls
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