Customer cancelled the return of the device to sechrist for inspection, their internal biomed department reported they fixed the issue but did not provide what was repaired on the mixer.No conclusions can be determined for failures reported.This customer is not one who has been trained and certified by sechrist for servicing mixer's.User's manual states: the sechrist air/oxygen mixer is a "precision pressure regulation and proportioning device, which is designed to accurately mix medical grade air and medical grade oxygen (02).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.Device history record review - mixer 3500 cp-g, serial number (b)(4) was manufactured on 11/11/2011.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.Based on the manufacturer date the device has been in service for eight years and there is no indication that the mixer has been sent to sechrist for a overhaul as required in the user's manual every two years.Trends found no limits were hit for the reported issue therefore, no further investigation or corrective/preventative action required.
|