Ropox 40-45027, User Manual

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TF 200.06.0006_ENG
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11 Accident reporting
The manufacturer of this product recommends any accident with this product that meets all of the following
criteria reported to the appropriate authority as well as to the manufacturer.
1. There has been or could have been an event
2. The medical device is considered to be a contributing factor to the case, and
3. The event resulted or could have resulted in one of the following outcomes:
•
death - a patient, a user or a third's death
•
A serious deterioration of a patient's health, a user's or third country's health status in the form of:
o
1. Life-threatening disease
o
2. lasting damage or injury
o
3. Necessary medical or surgical treatment to divert life-threatening illness, permanent injury
or mischief
o
4. fetal death, fetal injury or congenital abnormalities.