(b)(4).Per the srt, during accuracy testing the o2 analyzer showed 34.2% which is greater than 3% on the ccm, which displayed 29.3%.During laboratory analysis, the product surveillance technician (pst) was not able to verify the issue.The returned o2 sensor was installed into a lab use only electronic patient gas system (epgs) and passed calibration after the initial warm-up period.The o2% output was measured at multiple set points and compared to an external o2 meter and the ccm reading; all measurements were within specifications.The direct current (dc) voltage measured within specification on the o2 sensor.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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