Details of the complaint: on 02/12/18, customer at community health network reported the transmitter (zm-541pa sn: (b)(6) was getting hot.Service requested/performed exchange.Investigation result: per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The device warranty began on 04/23/15, and the issue occurred after almost 3 years at the customer facility.Review of device c4c history found no additional issue reported for the unit.Evaluation of the unit at nka was unable to reproduce the heating.The spring contacts were found to have one badly bent spring, and the inside shield showed signs of fluid intrusion.Zm-540pa operator's manual advises the following: this transmitter is not waterproof.If detergent or liquid spills into the transmitter, stop using it and contact your nihon kohden representative.If a wet transmitter is used, the patient or operator may receive an electrical shock or injury.The root cause is determined to be damage to the unit due to fluid intrusion.Investigation conclusion: the root cause is determined to be damage to the unit due to fluid intrusion.
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