It was reported that, during npwt, the renasys go caught fire.The device has been in use since (b)(6) 2022.Treatment was resumed with a back-up device.Current health status of the patient is ok, no damage/burns caused to the user.
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It was reported that, during npwt, the renasys go caught fire.The device has been in use since (b)(6) 2022.Treatment was resumed with a back-up device.Current health status of the patient is ok, no damage/burns caused to the user.
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Additional information: d4, b4.H10: the device was returned for evaluation, confirming the reported event.Visual inspection of the device found fire damage to the outside casing of the device.The damage was limited to the exterior, with no signs of fire damage inside the device.Even with the damaged casing, a functional evaluation found that the device operated as intended, with no faults found.A documentation review found no manufacturing or process quality that may have contributed to the reported event, with no historical escalations observed.A historical review found one previous complaints of this nature, in which the investigation confirmed device did not contribute to the reported event.It can be confirmed that this device also did not contribute to the reported fire.With there being no likely link between the device and the fire, other than location, no link to the risk files can be made and no further action with regards to the product risk files can be carried out.Probable root cause of the fire damage to device is that device was exposed to a flame/heat source.Evidence does not suggest that the fire originated from the device, due to the device interior being in a good, working condition.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.Internal complaint reference number: (b)(4).
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