A Structured Approach for Investigating the Causes of Medical Device Adverse Events

Table 1

Shepherd’s classification of medical device incidents [14].

Device	Operator	Facility	Environment	Patient
(i) Human factors design; (ii) Parts/circuit design: unexpected failure; (iii) Deterioration: predictable failure that requires preventative maintenance (e.g., battery); (iv) Maintainer error	(i) Education/training; (ii) “Use” error; (iii) Diverted attention; (iv) Criminal intent	(i) Human factors design; (ii) Parts/circuits designs: unexpected failure; (iii) Deterioration: predictable deterioration that requires preventative maintenance; (iv) Maintainer error	(i) Internal to hospital; (ii) External to hospital	(i) Active: patient action affected the outcome; (ii) Passive: patient’s condition affected the outcome