An outside the united states (ous) customer contacted a siemens technical applications specialist (tas).A siemens personnel was dispatched to customer¿s site.The siemens personnel removed the back panel of the atellica ch, observed a small puff of smoke emitted from the inside of the panel, found a burnt-out fuse, and the fuse housing was hot.Then, the siemens personnel shut down the system and took off all reagents and put parafilm on them.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse inspected the system and determined the damage was concentrated on the direct current ¿ device controller module 2 (dc-dcm2) board, where fuse 1 (f1) and fuse 2 (f2) were burnt.The cse inspected the wire harness, the sample arm, mixer fluidics heater and lysing agent cooling, but no abnormities were found.The cse checked the resistance of the mixer fluidics heater, lysing agent peltier cooler and their related thermistors, which had resistances equal to the expected levels, except for the peltier cooler on the lysing agent station.The cse replaced f1 and f2, turned on the power, and smoke came out from dc-dcm2.The cse removed connector 1 and connector 2 (oc1&oc2) at the back of dc-dcm2, turned on the power, and smoke was observed during boot.Then, the cse opened the dc-dcm2 cover and found a burned circuit board.In a subsequent visit, the cse replaced the dc-dcm2, the mixer fluid heater, and as a precaution the hybrid device controller module (cn) 14 and 15.Temporarily, the cse disconnected the lysing agent cooler, the thermal electric device (ted), and the thermistor.The system was successfully rebooted without incident.The cse successfully performed the daily maintenance.The instrument is performing according to specifications.No further evaluation of this device is required.
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Siemens filed initial mdr 2432235-2023-00253 with the fda on 14-sep-2023.Additional information (12-mar-2024): in addition to the components that were replaced in the initial report, the customer service engineer (cse) also replaced the thermal electric device (ted), thermistor, and lysing agent cooling assembly.Siemens reviewed manufacturing information for this instrument and did not identify any anomalies that could have contributed to this event.Lysing agent thermals were normal during testing in manufacturing.The atellica solution is manufactured to comply with both tuv ((b)(4), technical inspection association) and international electrotechnical commission (iec) standards for safety.Electrical components may produce a burning smell upon failure without risk of fire.The overall risk of fire from this incident is, and remains, limited.At this time, this is an isolated incident due to one or more defective malfunctioned components.The investigation conclusions code in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.
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