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This document is a notification regarding a voluntary field action related to the Companion External Batteries used with the Companion 2 Driver System due to potential thermal events caused by a manufacturing
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice
01
Begin by identifying the product affected by the safety issue.
02
Include the date on which the notice is issued.
03
Clearly state the nature of the safety concern and its potential risks.
04
Provide specific instructions on the actions recipients should take.
05
Include contact information for further questions or assistance.
06
Add any necessary product codes, batch numbers, or serial numbers.
07
Ensure the notice is distributed to all relevant parties promptly.
Who needs Urgent Field Safety Notice?
01
Healthcare providers who use the affected product.
02
Patients who are using the product or may be impacted by the safety issue.
03
Distributors and retailers of the product.
04
Regulatory authorities monitoring product safety.
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People Also Ask about
What is a field safety notice?
Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.
What is an example of a field safety corrective action?
The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has
What is field safety?
Development of field safety plans is critical for identifying and mitigating risk in the field. These plans allow you to prepare for situations you may encounter and know how to respond. The purpose of the plan is to make sure all staff and students are not caught unprepared and are aware of hazards they may encounter.
What is a FSCA in medical devices?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
What is a field safety notification?
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.
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What is Urgent Field Safety Notice?
An Urgent Field Safety Notice (UFSN) is a communication sent by a manufacturer or supplier to inform users of a medical device about a safety issue that requires their immediate attention.
Who is required to file Urgent Field Safety Notice?
Manufacturers, distributors, and authorized representatives of medical devices are required to file an Urgent Field Safety Notice if they identify a safety issue that could affect patient safety.
How to fill out Urgent Field Safety Notice?
To fill out an Urgent Field Safety Notice, you should include details such as the product details, nature of the safety issue, recommended actions for users, and contact information for further inquiries.
What is the purpose of Urgent Field Safety Notice?
The purpose of an Urgent Field Safety Notice is to alert users to potential risks associated with a medical device and to provide guidance on how to mitigate those risks.
What information must be reported on Urgent Field Safety Notice?
The information that must be reported includes device identification details, description of the issue, potential risks, recommended actions, and the timeline for follow-up or resolution.
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