The field service representative (fsr) states during a diagnostic check on the alinity i processing module, serial number (b)(6), a loud noise was heard and smoke appeared at the back of the instrument.The field service representative (fsr) determined the power supply was damaged.The fsr replaced the main power supply of alinity i to resolve the issue.Control run passed.No impact to patient management was reported.
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The field service representative (fsr) states during a diagnostic check on the alinity i processing module, serial number (b)(6), a loud noise was heard and smoke appeared at the back of the instrument.The field service representative (fsr) determined the power supply was damaged.The fsr replaced the main power supply of alinity i to resolve the issue.Control run passed.No impact to patient management was reported.
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Service determined the main power supply, processing module (part number a-30103383-02) the likely cause for observed smoke.The main power supply, processing module (part number a-30103383-03) was installed to replace part number a-30103383-02.Installation of the main power supply, processing module (part number a-30103383-03) resolved the issue.Return testing was not completed as returns were not available.A review of the alinity i processing module, serial number (b)(6) service history, revealed no additional issues of smoke from a part reported on the (b)(6).A review of tracking and trending did not find any related trends of the main power supply, processing module or the alinity i processing module with regards to the complaint issue.The device history record was reviewed and identified no non-conformances or deviations associated with the complaint issue.The 2024 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The loud noise and smoke observed was limited to main power supply, processing module; the loud noise and smoke did not spread to other parts of the module.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the main power supply, processing module and the alinity i processing module, serial number (b)(6).
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