(b)(4).Additional information received indicating the issue was detected prior to use on a patient.The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit failed the initial power connect test.The unit was not recognizing power which could mean a blown fuse, a faulty power supply board or failure of the power entry module/harness.First, the unit was opened and the power supply pcba was removed.There was evidence of burnt components on the board and on the metal plate on which the board sits.A known good lab inventory power supply pcba was connected to the device and this time, the unit passed the initial power connect test.The unit also navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The reported complaint of "unit is not heating" is confirmed.The sample was returned with a defective power supply pcba.A device history record review was performed with no evidence to suggest a manufacturing related issue.Each concha neptune device is inspected 100% during manufacturing assembly, it is unlikely that this defect was present at the time of release.The device was designed for a minimum of 5 years.Based on the information available, it appears that unintentional user error - normal wear caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
|