It was reported that during treatment the patient heard a bang and could smell smoke, initially it would appear that the plug has some sign of melting, however this is not confirmed, no photos are available.Additionally, the wife removed the plug and there was a spark at the plug/socket.Neither the patient or his wife have any sort of injury and neither sought medical attention.No backup device was available and a delay greater than 2 hours was reported.
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H10, h3, h6: the device, used in treatment, has been returned and evaluated.A visual inspection reported defects to the outer case and the main power charging port was found broken.The functional assessment found the device was unable to be charged due to this defect, there was no signs of overheating found on the device.A relationship between the reported overheating event and the device was not established.Although a definitive root cause could not be established, it is likely that the device would have felt warm to the touch, whilst it was attempting to charge, due to the damaged charging port.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported events has been reviewed, revealing further instances.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.
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