H3, h6: the device, used in treatment, has been returned for evaluation.A visual inspection found no defects.The functional evaluation found the device was unable to start up free from critical errors, establishing a relationship between the events reported.The root cause has been identified as software failure.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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