The device used in treatment, has been returned and evaluated.A visual inspection reported no defects.The functional assessment confirmed, that the device could not generate or control negative pressure.And could not generate alarms under the expected conditions, establishing a relationship with the reported event.The root cause was identified, as a defective vacuum motor.A review of the associated batch manufacturing records confirmed, that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.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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