Evaluation of the returned device found the unit is out of calibration.
Visual inspection also found one of the two set screws is missing, the fio2 adjustment shaft is topped and not making contact with the double taper needle.
The fio2 and balance regulator are out of calibration due to the knob slipping on the shaft.
Sechrist recommends completing daily, weekly and semi-annual performance verification on the device to detect any issues and preclude the device from use.
In instances where the device is found to function outside of specification, sechrist should be immediately notified for technical assistance.
Based on the age of the device, it is unlikely that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.
Therefore, no corrective or preventative actions are necessary.
All complaints are trended and reviewed by management on a monthly basis.
As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.
Manufacturer reference file no.
(b)(4).
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