mediprema AMBIA Parts list manual

FSNRef: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)
1
Date: 21/11/2022 (Translated on2022-12-08)
Urgent - SafetyNotice
Reminderof the instructionsforuseof
the infantradiant warmerfornewborns FABIE(Ref. 4300)
and the AMBIA care cradle (Ref. 4356 and4357)
Tothe attention of:
The local materialovigilance correspondent
And/or thematernity and neonatal departments
And/or the Director of the establishment
Contact informationforlocal representative
If you have any questions about this recall, please contact :
Salesdepartment:[e-mail] /[phone]
After sales services : [e-mail]/ [phone]
Quality department: [e-mail]/ [phone]

FSNRef: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)
2
1. Information on the products concerned
1.
1. Type(s) of product
This safety notice appliesto infantradiantwarmer FABIE (Ref. 4300) and care cradles AMBIA
(Ref. 4356 and 4357) for newborns.
This notice does not applyto AMBIA (Ref. 4351,4352, 4353,4354, 4355).
1.
2. Trade name
FABIE radiantincubator for newborns (Reference 4300).
AMBIAcare cradles fornewborns (Ref. 4356 and 4357).
1.
3. Primary clinical purposeof the device(s)
The FABIE-AMBIA radiantincubator isdesigned tomaintain the thermal balance ofa newborn
by direct radiation of infrared energy.
1.
4. Reference(s) of the device(s)
Catalog number: 4300,4356,4357
1.
5. Software version
Software version 1.0 or 1.1
1.
6. Serial numbers orbatches concerned
All FABIE-AMBIA devices, References4300, 4356, 4357with a incline / declinesystem, put on
the market.
2. Reason for the Corrective Action (FSCA)
2.
1. Description ofthe problem
Please be advised that an error in use has been reported during the nursing of a newborn with a
FABIE radiant incubator(Ref.4300).
The purpose of this safety 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.
2.
2. Risk that caused this SafetyCorrective Measure (FSCA)
Fall of a newborn resulting fromthe manipulation ofthe FABIE infant radiantwarmer(Ref.4300) bya
not intended user (parent).
2.
3. Probabilityof occurrenceof the problem
2 incidentsinvolvingtwopatientshavebeenreportedon 741FABIEinfantradiantwarmer(Ref.4300)
put on the marketsince 2006 in France (1761 salesin the world).
The risk associated with errors in using the infant radiant warmer wasidentified by inits
risk analysesbefore the incident occurs.
2.
4. Additional informationto characterizetheproblem
Use of the infantradiant warmer bya user notintended by
Non-compliancewith the instructions for use inthe usermanual.

FSNRef: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)
3
2.
5. Backgroundof theproblem
After theparents haveplaced thenewbornonthe infantradiantwarmer's sleeping surface, thecorrect
positioning and safety of the child has not beenverified by the medical staff, including the use of the
incline / declinesystem and the locking of the protective screens (foldable screens).
The manipulation of the device by parents must be supervised by medical personnel previously
trained in its use.
When activation of the incline / decline system, it is necessary to make sure that the screen at the
front of the sleeping surface is in the upright position and locked. The child must not be left
unsupervised if the screen isopened.
3. Action to be taken to mitigate the risk
3.
1. Measures to be takenbythe user
☒IdentifyDevice ☐Quarantine Device ☐ReturnDevice ☐DestroyDevice
☐ On-sitedevicemodification/inspection☒Followpatientmanagementrecommendations
☐ Take note ofamendment/reinforcementofInstructionsFor Use (IFU)
☐ Other ☐None
We would like to remindyou of the instructions for use,availablein youruser manual:
- § 4.1 Foldable screens, for FABIE (Ref. 4300) et AMBIA(Ref 4356 & 4357)
- § 4.6 Bedding trayincline/decline,for FABIE (Ref.4300)
- § 4.8 Care cradle incline,for AMBIA (Ref. 4356 & 4357).
Foldable screens (FABIE-AMBIA care cradle)
The screens can be folded down or removed.
To close the screens, proceed To removethem,slidethetwo
To fold the screensdown,pull in the reverse order by folding hinge pins out, one after the
them slightly upwards (1)and up the screens (1) then make other(1), then remove the
then tilt them outwards (2). sure they go down (2) after screen (2).
reaching theverticalpositionto
ensurea correct locking.
1
2

FSNRef: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
Never leave the device unattended while the screens are folded down: risk of the infant
falling out.
Check that allscreens are properly closed before leaving the newborn without supervision,
especially after any intervention of a person not trained in the use of this medical device
(parents, etc.).
Make sure that decline noitem(blanket, cloth…)interfere with the locking ofthe screens.
FABIE - Bedding tray incline/decline
The tilt position isadjusted byholding the traywith the left hand, and pulling the leverlocated under
the tray on the right with the righthand.
Pull completely the lever(1) then adjust the tilt of the tray (2), withoutapplying excessive force onthe
tray. Release the lever (1)to lock the tilt.
2
1
When the lever is pulled, the tray should pivot effortlessly. Always completely pull the
lever to ensure the gas spring is correctly unlocked before trying to adjust the tilt of the
tray. If the tray pivot with difficulty although the lever is pulled, or if the tray does not lock
when the lever is released, stop using the device and contact Médipréma Customer
Service.
The baby can slip if the tray is in a highly tilted position. Loops are provided for use
with retaining straps to prevent this. Medical personnel are responsible for deciding
whether or not to use them. Always check the side screens are locked, falling hazard.
The Fabie Infant warmeris designed to distribute heat uniformly over the entire surface of
the bedding when it is in the horizontal position. Obviously, during use when tilted, the
temperature is greater at the highest point (and correspondingly lower at the lowest
point). When the tray is in the maximum feet-upposition, the temperature at the top edge
is 3°C higher than the temperature at the center of the mattress. Consequently, the head
or the feet of the newborn will be warmer (depending on his or her position); therefore, it
is necessary to adjust the control temperature as a function of temperature reactions of
the baby.

FSNRef: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)
5
AMBIA - Care cradle incline
1 –Push the handle toward the inside
2 –Lower the bedding,without applying excessive force.
To raise the bedding just pushon the handle.A gas
spring will automatically raise the bedding.
When the handle is pushed, the tray should 2
pivot effortlessly. Always completely push
the handle to ensure the gas spring is
correctly unlocked before trying to adjust
the tilt of the tray. If the tray pivot with
difficulty althoug the lever is pulled, or if the 1
tray does not lock when the lever is released,
stop using the device and contact
Médipréma CustomerService.
The baby can slip if it is in the maximum tilt position. Loops are provided for use with
retaining straps to prevent this. Medicalpersonnelare responsible for deciding whether or
not to use them.
Therefore, we inform you that all users of the device must be trained in its use. The use of thedevice
is reserved for suitably trained persons and under the directionof qualified medical personnel who are
informed of the risks and benefits associated with the useof the FABIE radiant incubator and AMBIA
care cradle
Training sessions can beprovidedonrequest.
If youhaveany questions regarding usertraining, pleasecontact themanufacturer, :
Salesdepartment: [e-mail]/[phone]
After sales service: [e-mail] /[phone]
Quality department: [e-mail] /[phone]
3.
2. Deadlineforimplementation
of these measures
January 23, 2023
3.
3. Is a response from the clientnecessary?
(see acknowledgementofreceiptformin
attachment)
No
3.
4. Measures taken bythe manufacturer
☒Reminderof the instructions for use
3.
5. Should the FSNbe communicated to the
patient/end user?
Yes, communication tothe end user
3
6. If yes, has the manufacturer provided additional information tailored to the patient/user in
an information letter?
No, reminder ofthe instructionsfor use already indicatedin the user manual.

FSNRef: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)
6
4. General information
4.
1. Type of notification FSN
New
4.
2. Otheradviceorinformation expectedin
the follow-up tothis notification
None
4.
3. Manufacturer's information
(For the contact information ofthe localrepresentative, seethe first page of this securitynotice)
a. Name
Médipréma
b. Address
ZA Node Park Touraine
470 rueGillesdeGennes
37310 Tauxigny
France
4.
4. The competent (regulatory) authority in
your country has been informed of this
communication tocustomers:
No
4.
5. Attached document(s) :
None
4.
6. Name / Signature
…
Qualityandregulatoryaffairsmanager
Transmission of this security notice
This notice should beforwardedto allaffected individualswithin yourfacility orto anyfacilitytowhich
you have transferred affected products (if applicable).
Please forward this notice to any other organization that may be impacted by these measures (if
applicable).
It is importantthatthisinformation and the resulting actions are regularly reiterated for as long as
necessary to ensure the effectiveness of the corrective actions taken.
Pleasereportany product-relatedincidentstothemanufacturer,distributororits localrepresentative,
and to the competentauthorityif applicable, asthisprovidesimportant feedback.