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FSN 20226CCSRC049URGENT Field Safety Notice Trilogy Eve O2, Trilogy Eve Universal, Trilogy EV300 Accuracy of FiO2 Delivery 01 MAR 2023 To: Name / Title / Customer Name Street Address City, State,

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How to fill out field safety notice template

01

Start by gathering all necessary information related to the safety issue

02

Identify the affected products or devices

03

Clearly describe the safety concern or issue

04

Include details on any harm or potential harm that could result from the issue

05

Provide instructions on how to mitigate the risk or resolve the issue

06

Include contact information for reporting or follow-up

Who needs field safety notice template?

01

Manufacturers of medical devices

02

Distributors of medical devices

03

Healthcare facilities using medical devices

04

Regulatory authorities

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What is field safety notice template?

The field safety notice template is a document used to notify authorities and customers about a product safety concern.

Who is required to file field safety notice template?

Manufacturers, distributors, or importers of medical devices are required to file a field safety notice template.

How to fill out field safety notice template?

You can fill out a field safety notice template by providing detailed information about the safety concern, affected products, risk assessment, and corrective actions.

What is the purpose of field safety notice template?

The purpose of field safety notice template is to ensure the safety of customers and prevent potential harm from defective medical devices.

What information must be reported on field safety notice template?

The field safety notice template must include information about the safety issue, affected products, potential risks, and proposed corrective actions.

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