" /> Device Use Error - CISMeF





Preferred Label : Device Use Error;

NCIt related terms : use error (device);

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];

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01/06/2025


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