The device intended for use in treatment was returned for evaluation, establishing 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 the failure 4006, coin cell is empty.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.Root cause is a depleted battery.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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