It was reported that the debridation of the wound started without issue but after one minute of functioning, the device made a little explosion and water started to come out through the hose that is introduced to the device.Then, the device gave a error warning signal and it did not work again.It did not get pressure and continuously released water through the hose.The procedure was completed with a smith and nephew back up device.No harm or injury reported.
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H3, h6: the device, used in treatment, was not returned for evaluation.The information provided was reviewed, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes may be an obstruction, component failure, or connection issue.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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