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PHILIPS Emergency Care and Resuscitation1/5F5N86100222A2020 SEP 4URGENT Medical Device Correction Philips Sterilizable Defibrillator Paddles Addendum to IFU to Add Insulation Resistance Test to Paddle
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How to fill out urgent medical device correction
How to fill out urgent medical device correction
01
Identify the urgent medical device correction notice received from the manufacturer.
02
Gather the affected medical devices that need correction.
03
Follow the instructions provided in the notice to fill out any necessary forms or documentation.
04
Provide any requested information about the affected devices, including serial numbers or lot numbers.
05
Complete any required actions specified in the notice, such as returning the devices for repair or replacement.
06
Keep a record of the correction process for future reference.
Who needs urgent medical device correction?
01
Healthcare professionals who use the affected medical devices in patient care.
02
Patients who have been implanted or are using the affected medical devices.
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What is urgent medical device correction?
Urgent medical device correction is a process used to address safety concerns related to a medical device that has already been distributed.
Who is required to file urgent medical device correction?
Manufacturers and distributors of medical devices are required to file urgent medical device correction.
How to fill out urgent medical device correction?
Urgent medical device correction can be filled out by submitting a form to the relevant regulatory authority.
What is the purpose of urgent medical device correction?
The purpose of urgent medical device correction is to address safety issues and prevent harm to patients.
What information must be reported on urgent medical device correction?
Information such as the specific device model, the reason for the correction, and the actions that will be taken must be reported on urgent medical device correction.
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