There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).Through follow-up communication livanova learned that at the pre-test before going in the procedure the knob was acting normally and that it became loose during the case.However, the pump speed was still controllable by the knob and the procedure could be completed without issues.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|