NCIt definition : An error associated with the use of a medical device, due to problems with the design
of the device or the manner in which the device is used, that causes or leads to inappropriate
device use or patient harm.;
Alternative definition : CDISC-GLOSS: User action or lack of action that was different from that expected by
the manufacturer and caused a result that (1) was different from the result expected
by the user and (2) was not caused solely by device failure and (3) did or could result
in harm. [FDA, Applying Human Factors and Usability Engineering to Medical Devices];