Complications during treatment have been reported for this failure mode, such as use of an alternative or competitor device to complete the procedure.As a result, this malfunction may necessitate an alternative treatment if the malfunction were to recur.This alternative treatment is considered medical or surgical intervention to preclude permanent damage to a body structure or body function.This event is considered reportable pursuant to 21 c.F.R.§803.
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H3, h6: we have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been further complaints reported with this failure mode in the past three years.As no product could be returned, a thorough evaluation of the device could not be carried out.The device was intended for use in treatment.It was reported that all indicator lights were solidly illuminated.This means that the device entered a non-recoverable error state.There are various reasons that the device may enter an error state, such as out of range negative pressure, out of range power supply and an error retrieving data.If the pump does enter an error state, it must be replaced.This is a patient safety feature.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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