1999 BME 272 Assignment 9

This assignment consists of two parts. Part one may be done in a group (of up to 4 persons), only one copy with all names need be turned in to Paul Clayton. Part two is to be done individually and turned in to Dr. King. Both sections are due November 18.

Part 1. 20 points

Remember MAUDE? (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM ) Get with one or more of your friends and do a designsafe analysis of any device reported in this database that resulted in a death. Try to determine the design flaw that caused the death via a web or other search. Write up this analysis as a group (designsafe report (1-2 pages) and written analysis (1-2+ pages).

The purpose of part one is to get you to work together as a group to learn designsafe, to look up a particular device in the literature, and to introduce you to forensics.

In 1999 the following topics were selected for group projects:

respirator ICD external DC defibrillators
O2 regulators Glucose test strips pacemaker leads
whirlpool baths Hydrotherapy glucose monitors
LVAD analgesia pumps enteral pumps
side rails patient lifters GI feeding tubes
OB vacuum unit Insulin pump pacemakers

Part 2. 30 points

Do a designsafe analysis of any device or process (not necessarily medical) that you are familiar with that has caused harm or injury. Your report will consist of an introductory section on the device and/or circumstances involved (~ 1 page), your designsafe report (1-3 pages), and your report as to a means of alleviation of the perceived problem (~ 1 page).

The individual device/processes listed in 1999 were:

bicycle door elevator
wheelchair crutches resuscitator
Hill-Rom beds electric blankets lawnmower
pH probe roller blades O2 concentrator
can opener air bag skateboards
handrails brakes ovens
pumping gas backpacks contact lens
Toyota Rav-4 pulmonary artery catheter cribs
bed rails hair dryers lasers
pet grooming irons tire swings
drills safety gates O2 conservers
uterine retraction devices hearing aids wheelchair release belt
crib mattress x-ray system coke dispenser
laryngoscope chainsaw cookies
ventilator curling iron hair dye