‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device;
ciallaíonn “teagmhas” aon mhífheidhm nó aon mheath i saintréithe nó i bhfeidhmíocht feiste a cuireadh ar fáil ar an margadh, lena n-áirítear earráid úsáide a tharla mar thoradh ar ghnéithe eirgeanamaíocha, mar aon le neamh-leordhóthanacht ar bith san fhaisnéis a sholáthair an monaróir agus aon dochar mar thoradh ar chinneadh leighis, ar an ngníomhaíocht a rinneadh nó nach ndearnadh ar bhonn na faisnéise nó na dtorthaí a cuireadh ar fáil leis an bhfeiste;