This report is related to initial report from importer oscor with importer report #: (b)(4).The device was returned to manufacturer and arrived on 28oct2019.Initial evaluation did not show any functional problem.The perspex protection cover was missing.The housing was damaged on the arm cuff brakets and lower housing body.Corrosion on the printed circuit board was found as a result of liquid ingress.Despite the mechanical damages, further evaluation did not raise any function defect causing sensing problems.The failure description could not be reproduced.The pacemaker works according to its specification.Possible causes for sensing failures could be: bad lead to tissue contact, unappropriate lead position, not correct adjustment of sensitivity threshold causing undersensing due to wrong sensitivity setting - to hight sensitivity values.Unfortunately there were no further details of the circumstances available which could explain the most likely root cause.The damaged housing, printed circuit board and prespex cover has been replaced and the device has passed safety and functional test and returned to the importer on 13jan2020.
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