The device, was used in treatment was returned for evaluation, could not establish a relationship between the event reported and the device.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed no fault found, 808a is the pressure test on start up, if it detects the pressure is outside the self test range, this alarm will display.No batch /lot number has been provided rendering a review of the device history not possible.A complaint history review found other related failures.Probable cause would likely be a system set up issue or an accessory component failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.
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