H3, h6: the device used in treatment was returned for evaluation and we have established a relationship between the device and the reported event.A visual inspection reported no defects.The functional evaluation revealed that leak alarm continuously sounded during operation and the root cause identified as a defective vacuum pump.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.G1 mdr reporting contact name and address.
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