It was reported that immediately after changing the dressing and resuming treatment, the message of blockage alarm was displayed on the screen.The problem was not solved by exchanging the two canisters.Eventually, the customer change the dressing again and switched the operation mode from ai mode to continuous operation and the alarm stopped.No surgical delay.Patient injuries were not reported.
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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.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review was performed for the product and failure mode reported, there have been further instances.Potential causes include, kinks, leaks and blockages in the vacuum circuit or 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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