The customer originally reported that the multigas unit just stopped working and shut down on its own.It was later reported that this unit had intermittent issues with the end tidal co2 readings and was not working consistently.There was no sign of physical damage or fluid intrusion and the unit was sent to nihon kohden for evaluation and repair.The unit was cleaned and evaluated.The reported issues could not be duplicated.Nihon kohden performed an air calibration and tested the gas functions, however no issues were found.The unit was tested per the service manual and the results were recorded on the maintenance check sheet.The unit completed 10 days of extended testing, never shut down during this period of time, and operates to manufacturer's specifications.The multigas unit was then returned to the customer.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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