(b)(4).During laboratory analysis, the product surveillance technician (pst) installed oxygen (o2) sensor into a lab use only electronic patient gas system (epgs) to a system 1 simulator and central control monitor (ccm).He connected the epgs to o2 and air, entered the perfusion screen on the ccm and waited the 15 minute warm-up period.After the warm-up period, the calibration of the epgs was initiated and passed.The measurement of direct current (dc) output voltage from the o2 sensor was at 5 l/min and 100% o2 was 1.58 volts which is within the specifications of.55-2.758 volts.Inaccuracies were found when he tested the o2% accuracy output at 80%.Per service repair technician (srt), the o2 sensor calibration test had a set point of 80%.The central control monitor (ccm) reported 80.5%, the actual value on the external gas analyzer was 77.4%.The srt replaced the o2 sensor.The epgs operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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