It was reported that during npwt utilizing renasys touch, the message of blockage alarm was displayed on the screen.The problem was solved by exchanging the device.There was no delay.There was no patient harm.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3, h6: the device, was used in treatment was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.No batch lot number has been provided therefore a review of the device history is not possible.A complaint history review found other related failures.Probable root cause maybe a component failure.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.
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