H6: the device used to be used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.However events of the reported event maybe due to power cord connection, no damage or free of defects, the instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, the reported file is held by the quality release team.The complaint history file contains further instances of the reported event however this investigation is now complete with no further action deemed necessary at this stage.
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