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Dear distributor,
attached to this letter you'll find an IMPORTANT SAFETY NOTICE regarding Micromed systems installed on
a CAR POLE cart.
Some of these systems or cart have been provided to the users through your company (see list in Annex 2).
We kindly ask you to inform all customers to which you provided the affected devices , by providing them the
attached document FSN18001, within 15 February 2018:
Formal confirmation must be provided to Micromed by filling and returning the specific form (annex 1) within
Friday 16 February 2018.
This Field safety Notice has been notified to the Competent Authority of your country (Ministry of health or
Medical Device agency) .
We'll then ask you cooperation for proceed with the corrective actions described in the Field Safety Notice.
We thank you in advance for the cooperation .
For any information or clarification, please contact directly our Quality and Regulatory office (Ms. Monica
Camillo,
regulatory@micromed.eu
Best regards
Annexes
- Annex 1 – Receipt Form to be returned filled and signed to
- Annex 2 – List of affected devices supplied to your company
- Field safety Notice FSN18001 document for the system users (7 pages)
, +39-041-5937000).
...
...
Micromed S.p.A.
regulatory@Micromed.eu
M19-01 Nota informativa
rev.1.06 del 30/08/2016
within 16 February 2018
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Summary of Contents for Micromed FSN 18001
- Page 1 We kindly ask you to inform all customers to which you provided the affected devices , by providing them the attached document FSN18001, within 15 February 2018: Formal confirmation must be provided to Micromed by filling and returning the specific form (annex 1) within Friday 16 February 2018.
- Page 2 FSN18001 ANNEX 1 RECEIPT CONFIRMATION (DISTRIBUTOR) Reference to FSN 18001 Reference to FSCA 18001 Product Code: CAR POLE From our data , it appear that some of these systems or carts have been provided to the users through your company.
- Page 3 FSN18001 ANNEX 2 LIST OF THE DISTRIBUTED CAR POLE CARTS...
- Page 4 . CORRECTIVE ACTIONS BY THE MANUFACTURER Micromed will change the user manual and the device labelling to provide more detailed instructions on the displacement of systems installed on a cart. Moreover, Micromed, to guarantee the maxiumum safety for the users of its systems, will proceed with the replacement of the cart bases with a sturdier model, modified to provide a greater resistance to impacts and stresses.
- Page 5 FSN18001 ACTIONS TO BE PERFORMED BY THE USER 1. . Verify the status of the cart base: if there are any crack, move no more the cart and contact Micromed to obtain priority in the corrective action 2. Immediately start following the improved safety instruction described in Annex A 3.
- Page 6 FSN18001 ANNEX A – MODIFIED SAFETY INSTRUCTIONS In the manual “Electroencephalography and evoked response digital acquisition systems and review stations - BRAIN QUICK - Technical Guide to safety, use and maintenance of the system” (document MBQ.EN ver. 1.04 of 9 February 2018) The precautions section has been modified and a section reporting the instructions for the correct displacement of the system has been added.
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Page 7: Device Maintenance
DEVICE MAINTENANCE 16. Inspect the containers, the accessories and the power and communication cables to notice eventual damages made by shipment and report all problems to your MICROMED S.p.A. representative before using the device. Rev. 1.04... - Page 8 Technical Guide to safety, use and maintenance of the system DISPLACEMENT OF THE SYSTEM The cart is designed to support the weight of the system. It must not be subjected to stresses deriving from additional loads. Do not lean on the keyboard tray when using the keyboard Do not climb or place your feet on the shelves or on the wheels of the trolley Do not lean heavily on the handle or push it down.
- Page 9 Technical Guide to safety, use and maintenance of the system The overcoming of differences in height (e.g. thresholds, steps, obstacles, fairleads) must be carried out by lifting the trolley completely and relocating it gently after the obstacle. This operation may require the presence of two operators.
- Page 10 FSN18001 ANNEX B RECEIPT CONFIRMATION (USER) Ref. to FSN 18001 Ref. to FSCA 18001 Product Code: CAR POLE From our data, you should have received a device affected by this Field Safety Corrective Action. We kindly asked you to return via fax (at the number 041/5937011) or email at regulatory@micromed.eu...
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