It was reported to covidien on (b)(6) 2016 that a customer had an issue with an epump.The customer states the motor/rotor failed, the door was damaged, and unit was smoky.With the unit emitting smoke, this complaint is reportable.
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An evaluation of the kangaroo pump was performed for the reported condition of, the motor/rotor failed, and unit was smoky.The unit was triaged and the reported issue was confirmed.Previously an investigation was performed by r & d regarding the issue of gearboxes prematurely wearing, which can cause the gearbox to rotate in reverse and the graphite dust possibly giving off a smoky odor.Per the r & d study the most likely cause of this issue is due to the shaft material that was used.Enhancements have been implemented to prevent the reported condition from recurring.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Post market trending is in place to monitor for further occurrences.If information is provided in the future, a supplemental report will be issued.
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