Additional information: h6- ec method code desc - 1: changed to testing of actual/suspected device (10).H6- ec method code desc - 2: changed to historical data analysis (4109).H6- ec results code desc - 1: changed to manufacturing process problem identified (170).H6- ec conclusions code desc - 1: changed to cause traced to manufacturing (25).H10- added summary of investigation.Investigation-evaluation: device was returned to cvi on 20apr2020.The device was used.When performing a visual inspection, the cuff was indeed detached from the crystal.Visual inspection confirmed the customer's complaint.The probe was inspected under magnification, there is epoxy on one side of the crystal, and the opposite side of the crystal did not have epoxy remaining.The device history record (dhr) was reviewed and showed no signs that the cuff was detached prior to shipment or that the device was not manufactured to current specification.This is a known failure mode, and is being tracked/trended per the post market surveillance and complaint handling processes at cvi.Crystal detachment from cuff is addressed per capa 161942.A risk assessment was performed via qera 171221.1.Per ifu (d00078672 rev003): "device specific risks include separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal after monitoring is complete, loss of reception or transmission of ultrasound monitoring signal." , "upon removal from package, inspect the product to ensure no damage has occurred." this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|