Chapter 13 Vigilance
42 000191-16 NIOX VERO
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User Manual English
13 Vigilance
Circassia, as a medical device manufacturer, must have a Vigilance system in
place to report to health authorities, any adverse incidents that have occurred
with its medical products.
The purpose of the Vigilance system is to ensure the health and safety of
patients, users and others using medical products by reducing the likelihood
of the same type of adverse incident being repeated. This is achieved by
immediate notification of incidents to enable corrective and preventive
actions.
An adverse incident is defined as: Any malfunction or deterioration in the
characteristics and/or performance of a instrument, or any inadequacy in the
labeling or instructions for use which might lead to or might have led to the
death of a patient or user or to a serious deterioration in his/her state of
health.
Manufacturers of medical devices are obliged to report adverse incidents to
national health authorities within 10 or 15 days, dependent on the severity of
the incident.
Any user of Circassia's products who experience an adverse incident related
to the product, must immediately report this to Circassia and the competent
authority of the Member State where the incident occurred.
The report can be made by e-mail, fax, or telephone. The report should
contain the following information:
• When and where did the incident occur?
• What product / accessory was involved?
• Was the incident related to instructions for use of the product?
• Was the risk foreseeable and clinically acceptable in view of potential
patient benefit?
• Was the outcome adversely affected by a patient's pre-existing
condition?
The report should be forwarded to Circassia's local representative as well as
the competent authority in the Member State where the incident occurred.
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