Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the customer-supplied photographs was performed and observed a device connected to the power line but was not powered up.A photograph of the serial number was provided but could not be read.A complaint history review concluded this was a repeat issue.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended a relationship, if any, between the subject device and the reported event could not be determined.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event potentially include a failing power supply or other electrical component.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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