(b)(4).The srt replaced the o2 sensor and the unit operated to manufacturer specifications and was returned to clinical use.During the laboratory evaluation, o2 sensor accuracy was within specifications.Nothing observed that would cause failure was noted during visual inspection.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).He 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 5 liters per minute (l/min) and 100% o2 was 1.71 volts (v) which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% and it met specifications as shown below: o2% set point = 100%, ccm reading = 99.0%, external analyzer reading = 97.9%; o2% set point = 80%, ccm reading = 79.9%, external analyzer reading = 79.6%; o2% set point = 60%, ccm reading = 59.5%, external analyzer reading = 59.5%; o2% set point = 40%, ccm reading = 39.9%, external analyzer reading = 39.9%; o2% set point = 21%, ccm reading = 20.8%, external analyzer reading = 21.3%.Specifications for oxygen accuracy, +/- 3% of o2 set point.Specifications of ccm, oxygen reading +/- 7% of o2 set point.
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Upon receipt of the device, the service repair technician (srt) reported that the oxygen sensor (o2) failed reading accuracy testing on the electronic patient gas system (epgs) during phase 2 testing.The o2 sensor failed reading at 21%: sensor reading 26.7% and servomex o2 analyzer reading 21.0%, acceptable result is +or- 3% per specification.There was no patient involvement.
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