(b)(4).This complaint is related to emdr #1828100-2016-00189.At set-point of 21%, the central control monitor (ccm) read 25.2%, servomex o2 analyzer read 20.9% which is outside the limit of +/- 3%.The srt installed another o2 sensor and ran applicable verification tests.The unit operated to manufacturer specifications and was returned to clinical use.During the laboratory evaluation, an epgs with the returned o2 sensor installed passed calibration but the o2% accuracy was not within specifications.After a second calibration, the o2% accuracy was within specifications.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 ccm.The pst connected the epgs to o2 and air, 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 five liters per minute (l/min) and 100% o2 was 1.92 volts which is within the specification of 0.55-2.758 volts.The pst observed nothing that would cause failure.The pst checked o2 accuracy and readings were outside specifications.Flow rate = 5 l/min, o2% set point = 100%, ccm = 100%, external analyzer = 98.8%.Flow rate = 5 l/min, o2% set point = 80%, ccm = 69.2%, external analyzer = 85.7%.Flow rate = 5 l/min, o2% set point = 50%, ccm = 41.4%, external analyzer = 52.3%.Flow rate = 5 l/min, o2% set point = 30%, ccm = 29%, external analyzer = 22.7%.Flow rate = 5 l/min, o2% set point = 21%, ccm = 19.9%, external analyzer = 17.5%.After one half hour, the pst repeated calibration and all results are within specifications after a second calibration.Flow rate = 5 l/min, o2% set point = 100%, ccm = 100%, external analyzer = 98.5%.Flow rate = 5 l/min, o2% set point = 80%, ccm = 79.6%, external analyzer = 77.1%.Flow rate = 5 l/min, o2% set point = 50%, ccm = 50.8%, external analyzer = 49.3%.Flow rate = 5 l/min, o2% set point = 30%, ccm = 30.1%, external analyzer = 29.8%.Flow rate = 5 l/min, o2% set point = 21%, ccm = 21.2%, external analyzer = 20.8%.
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