The device intended for use in treatment was returned for evaluation, establishing a relationship between the event reported and the device.A visual inspection was performed and showed no damage to the device.The functional evaluation found that the device could not maintain pressure and the root cause identified as a defective vacuum motor, battery and mainboard.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A 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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