The device sample was returned to the manufacturer for evaluation, but the investigation is incomplete at the time of this report.Per dhr (device history record) review of the product concha neptune, serial number (b)(4) was manufactured on 12/19/2007.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.Note: there is no alarm for the water level for conchatherm neptune units.Teleflex will continue to monitor and trend relating complaints.
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