An evaluation could not be completed due to the material in question was discarded at the customer site.The customer was not aware the fetal spiral electrode (fse) tip had broken off and disposed of the fse without checking the tip.Capa (b)(4) was opened to investigate the fetal spiral electrode tips breaking off as well as (b)(4), clinical assessment (b)(4) and regulatory compliance evaluation (b)(4).The instructions for use directs the user how to remove the fse and inspect the tip for any breakage.Philips sent a communication to users to remind them of these important directions.No further investigation or action is warranted.An evaluation could not be completed due to the material in question was discarded at the customer site.
|