This medwatch report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The carefusion fse was unable to the record settings due to the settings being changed prior to onsite visit.The unit piston centering on the unit needed calibration.The fse was unable to duplicate customer complaint.Performed the 2k pm, ddi calibration, pneumatic calibration and the final test.Performed ovp test and unit passed all test per manufacturer specification.
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