The reported device, used in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed the device was not recognized when plugged in.Further investigation revealed an internal damage to the cord.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event include a damaged cord.A review of the device history records showed there were no indications to suggest that the device did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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