1. Patient Hazards Jessica Brisbin Alexandra Jefferds Nichole McPherson Nick Werner ABCD Fault Tree for the ECI Device Final Revision: 4/17/06

2. Device interferes with medical procedure. Clinician finds device distracting. Patient overreacts to device. Clinician thinks music is too loud. Patient thinks music is too loud. Patient is hyper- sensitive to noise. Clinician is tired of hearing the same song over and over. LEDs distract clinician. Vibration of arm with device conducts to arm of injection. A Jessica Brisbin Alexandra Jefferds Nichole McPherson Nick Werner

3. Patient has a seizure disorder. Device is a direct hazard to patient. Electrical interference with other devices. Arm band disrupts blood flow. Speakers emit sound waves. Band is applied too tightly. Components emit EM radiation. Flashing of LEDs. Device causes a seizure in patient. Patient has an allergy. Arm band is not hypo- allergenic. Device causes an allergic reaction in patient. B Jessica Brisbin Alexandra Jefferds Nichole McPherson Nick Werner

4. Device won’t stay on the limb. Patient’s arm is too small for the strap. Patient’s arm is too large for the strap. Strap doesn’t fit around the arm. Strap cannot be replaced with a larger one. Strap doesn’t fit around the arm. Strap cannot be replaced with a smaller one. Strap connection comes apart. Strap breaks. Strap material is inadequately strong. Strap is subjected to extreme loads. Velcro is dirty. Velcro is inadequately adhesive. C Jessica Brisbin Alexandra Jefferds Nichole McPherson Nick Werner

5. Device can’t be operated (safely). Switch doesn’t work. Device stops working. Switch breaks. Case cracks. Switch is difficult to operate. Switch is stiff. Switch is too small. Device is submerged in liquid. Electrical connection breaks. Device is dropped. Strong connection was not made to begin with. Device electrocutes clinician or patient Device is submerged in liquid Electrical component breaks. D Jessica Brisbin Alexandra Jefferds Nichole McPherson Nick Werner