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Table of Contents
- 1 Information on the Products Concerned
- 2 Reason for the Corrective Action (FSCA)
- 3 Action to be Taken to Mitigate the Risk
- 4 FABIE - Bedding Tray Incline/Decline
- 5 Measures Taken by the Manufacturer
- 6 AMBIA - Care Cradle Incline
- 7 General Information
- 8 Transmission of this Security Notice
- Download this manual
Date: 21/11/2022 (Translated on 2022-12-08)
the infant radiant warmer for newborns FABIE (Ref. 4300)
To the attention of:
The local materialovigilance correspondent
And/or the maternity and neonatal departments
And/or the Director of the establishment
Contact information for local representative
If you have any questions about this recall, please contact
Sales department :
service.commercial.france@mediprema.com
Af ter sales services :
Quality department :
1
Reminder of the instructions for use of the infant radiant warmer FABIE (Ref. 4300)
Urgent - Safety Notice
Reminder of the instructions for use of
and the AMBIA care cradle (Ref. 4356 and 4357)
sav@mediprema.com
qualite@mediprema.com
FSN Ref
: FSN_Mediprema_FABIE AMBIA_20221121
and the AMBIA care cradle (Ref. 4356 and 4357)
/ +33 (0)2 47 28 23 86
/ +33 (0)2 47 28 36 86
/ +33 (0)2 47 29 49 34
:
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Related Manuals for mediprema AMBIA
Summary of Contents for mediprema AMBIA
- Page 1 FSN Ref : FSN_Mediprema_FABIE AMBIA_20221121 Reminder of the instructions for use of the infant radiant warmer FABIE (Ref. 4300) and the AMBIA care cradle (Ref. 4356 and 4357) Date: 21/11/2022 (Translated on 2022-12-08) Urgent - Safety Notice Reminder of the instructions for use of the infant radiant warmer for newborns FABIE (Ref.
- Page 2 FABIE radiant incubator (Ref.4300). The purpose of this saf ety notice is to remind you of the instructions for use of our FABIE -AMBIA devices, to permit you to assure the safety of the newborn, through the correct use of the incline / decline system and the correct positioning of the foldable screens.
- Page 3 ☐ None We would like to remind you of the instructions for use, available in your user manual: § 4.1 Foldable screens, for FABIE (Ref. 4300) et AMBIA (Ref 4356 & 4357) § 4.6 Bedding tray incline/decline, for FABIE (Ref.4300) §...
- Page 4 : FSN_Mediprema_FABIE AMBIA_20221121 Reminder of the instructions for use of the infant radiant warmer FABIE (Ref. 4300) and the AMBIA care cradle (Ref. 4356 and 4357) Never leave the device unattended while the screens are folded down: risk of the infant falling out.
- Page 5 Therefore, we inform you that all users of the device must be trained in its use. The use of the device is reserved for suitably trained persons and under the direction of qualified medical personnel who are informed of the risks and benef its associated with the use of the FABIE radiant incubator and AMBIA care cradle Training sessions can be provided on request.
- Page 6 FSN Ref : FSN_Mediprema_FABIE AMBIA_20221121 Reminder of the instructions for use of the infant radiant warmer FABIE (Ref. 4300) and the AMBIA care cradle (Ref. 4356 and 4357) 4. General information 1. Type of notification FSN 2. Other advice or information expected in...
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