Team Members: Anna Dirienzo, Katelyn Lesk, Amber Loree, Jude Menie

Team Members: Anna DiRienzo, Katelyn Lesk, Amber Loree, Jude Menie

Project: Support Device for iSCAN

Mentors: Daniel McChesney, MD and Nobuhiko “Poohsan” Tamura, Ph.D.

4/11/06

FMEA

Component / Failure Mode / Effect on System / Possible Hazards / Risk Index / User Detection Means / Applicable Control(s)
Base (IV pole) / Operator Error / Inadequate Stabilization (moving or tipping) / Improper ICP reading; injury to the patient’s eye / 10 / Operator sees visible signs of apparatus instability / Locking wheels to prevent unwanted movement; weighted base to decrease likelihood of tipping
Gooseneck Positioning Arm / Mechanical Failure / Difficult system positioning / Injury to patient’s eye; damage to the iSCAN device / 14 / Operator sees visible signs of apparatus falling toward the patient, floor / Gooseneck is capable of supporting the full weight of the device with a factor of safety of ~2
Steering Handle / Mechanical Failure / Loss of control over stabilization of iSCAN / Injury to patient’s eye; damage to the iSCAN device / 15 / Operator sees visible signs of loose connections between handle and IV pole / Handle is capable of supporting the full weight of the device with a factor of safety of ~2
90-degree L-plate / Mechanical Failure / Loss of control over stabilization of iSCAN / Injury to patient’s eye; damage to the iSCAN device / 10 / Operator sees visible signs of bending of L-plate beyond 90-degrees / L-plate is capable of supporting the full weight of the device with a factor of safety of ~2
Fine Adjustment Component(s) / Operator Error / Too much, or too little pressure applied to the eye / ICP measurements are abnormal, or undetected / 11 / Operator should notice inaccurate pressure readings / Operator should be taught how to correctly operate the device and should perform routine calibrations
Fine-Adjustment Component(s) / Mechanical Failure / Lack of control over increasing pressure on the eye / Damage to the patient’s eye / 10 / Operator will notice a lack of fine control over the iSCAN device / Periodic testing and maintenance of the fine-adjustment component(s)
Entire System / Operator Error / Either total lack of or poor sterilization techniques / Unexpected infection in the patient’s eye / 18 / Visual inspection of the eye piece / Implementation of a cleaning regiment to be carried out after each measurement

Risk Index

Probability of Occurrence / Severity I:
Catastrophic
(Death, serious injury) / Severity II:
Significant
(Reversible serious injury) / Severity III:
Marginal
(Inconvenience) / Severity IV:
Negligible
Frequent / 1 / 3 / 7 / 13
Probable / 2 / 5 / 9 / 16
Occasional / 4 / 6 / 11 / 18
Remote / 8 / 10 / 14 / 19
Improbable / 12 / 15 / 17 / 20