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User questionnaire
Defibrillator RESCUE SAM

Dear user,

PROGETTI S.r.l., as the manufacturer of the RESCUE SAM Defibrillator, collects and evaluates clinical data relating to its use on patients to confirm its safety and performance for its entire expected life, while ensuring the unchanged acceptability of the well noted risks and identifying other emerging ones.

Therefore, we ask you to take a few minutes to complete this questionnaire. For us, each answer is a precious contribution to continuous improvement.

Thank you!

N.B. Omissions do not include the absence of information that must generally be known by the intended USER.
N.B. A "serious deterioration" in health can include (but is not limited to):
a. Life-threatening disease;
b. Permanent injury/damage to a body structure/function;
c. A condition that requires medical or surgical intervention to prevent (a) or (b);
d. Need for hospitalization or hospitalization extension;
e. Any indirect damage as a result of indirect diagnostics when the device is used according to the MANUFACTURER's instructions for use;
f. Fetal distress, fetal death, or any congenital abnormality or birth defect.
Clear Signature
The data processed will be protected in compliance with the applicable requirements of the Regulation (EU) 2016/679 of 04/27/2016

Ref. EN ISO 13485:2016+A11:2021 – Quality Management System - MDR 2017/745 – Medical Devices

For furthe rinformation: quality@progettimedical.com