The sechrist equipment was functionally checked, by service technician, without any deviation from specifications identified.No out of range values for fio2 delivery were measured and no alarm monitoring system issue was reproduced.Unit was found to be working properly.Based on service record results, provided by the customer, the unit was serviced and released for patient use.Therefore, no corrective or preventive actions are necessary.As indicated in the user's manual, as part of performance verification, the user shall "prior to each clinical usage, the user should perform an alarm test and analyze the full fio2 range.With an accurately calibrated oxygen analyzer, the user should analyze the fio2 at the following settings; 21%, 40%, 60%, 80%, and 100%.Additionally, the user should briefly disconnect one supply gas to assure that the bypass/alarm system is functioning.With a single supply gas disconnected, the audible alarm should sound and the analyzed fio2 should indicate the fio2 of the single supply gas; i.E.21% if the oxygen was disconnected and 100% if the air supply was disconnected." furthermore, the sechrist blender must be overhauled every 2 years.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file no.(b)(4).
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