IMPORTANT MEDICAL NOTICE
Any serious incident should be reported to the manufacturer Impulse
Dynamics by emailing
.
According to MDR 2017/745, a ‘serious incident’ means any incident that
directly or indirectly led, might have led, or might lead to any of the
following:
a) The death of a patient, user, or other person,
b) The temporary or permanent serious deterioration of a patient’s,
users, or other person’s state of health. A serious deterioration in
the health of the subject, that resulted in any of the following:
i. Life-threatening illness or injury,
ii. Permanent impairment of a body structure or a body
function,
iii. Hospitalization or prolongation of patient hospitalization,
iv. Medical or surgical intervention to prevent life-threatening
illness or injury or permanent impairment to a body
structure or body function,
v. Chronic disease,
c) A serious public health threat. A public health threat is an event
which could result in imminent risk of death, serious deterioration
in a person’s state of health, or serious illness, that may require
prompt remedial action, and that may cause significant morbidity
or mortality in humans, or that is unusual or unexpected for the
given place and time.
