(b)(4).This complaint is related to emdr #1828100-2016-00200.The srt installed another new o2 sensor and ran applicable verification tests.The unit operated to manufacturer specifications and was returned to clinical use.During the laboratory evaluation, the o2 sensor accuracy was not within specifications during initial testing after calibration.Nothing was observed visually that would cause failure.The product surveillance technician (pst) installed the returned o2 sensor into a lab-use only (luo) epgs and connected the epgs to a system-1 simulator and central control monitor (ccm).The pst connected the epgs to oxygen and air and entered a perfusion screen on the ccm.After the 15 minute warm-up period, calibration of the o2 sensor was initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 1.94 volts which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% and found inaccuracies as shown below: flow rate = 5 l/min, o2% set point = 100%, ccm = 88.4%, external analyzer = 98.9%.Flow rate = 5 l/min , o2% set point = 80%, ccm = 78.2%, external analyzer = 88.8%.Flow rate = 5 l/min, o2% set point = 50%, ccm = 49.5%, external analyzer = 57.7%.Flow rate = 5 l/min, o2% set point = 30%, ccm = 29.4%, external analyzer = 34.8%.Flow rate = 5 l/min, o2% set point = 21%, ccm = 16.8%, external analyzer = 20.5%.After 20 minutes of testing, a second calibration was performed and the o2% accuracy then met specifications as shown below: flow rate = 5 l/min, o2% set point = 100%, ccm = 100%, external analyzer = 98.7%.Flow rate = 5 l/min, o2% set point = 80%, ccm = 80.0%, external analyzer = 79.1% flow rate = 5 l/min, o2% set point = 50%, ccm = 49.1%, external analyzer = 49.1%.Flow rate = 5 l/min, o2% set point = 30%, ccm = 30.1%, external analyzer = 30.6%.Flow rate = 5 l/min , o2% set point = 21%, ccm = 19.7%, external analyzer = 20.4%.
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