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Specifies the FABIE radiant warmer and AMBIA care cradle models covered by this safety notice.
Lists the trade names for the affected products: FABIE radiant incubator and AMBIA care cradles.
Explains the main function of the FABIE-AMBIA radiant incubator for maintaining newborn thermal balance.
Provides catalog numbers for the affected devices, including FABIE (4300) and AMBIA (4356, 4357).
Indicates the relevant software versions for the devices, specifically 1.0 or 1.1.
Details specific serial numbers or batches concerned, including devices with an incline/decline system.
Details a reported error in the use of the FABIE radiant incubator during newborn nursing.
Explains the risk of a newborn falling due to improper manipulation by an unintended user.
Reports incident statistics and findings from risk analyses conducted before the incident.
Notes issues like use by unintended users and non-compliance with instructions.
Elaborates on the context, including lack of verification of correct positioning and supervision.
Outlines user actions: identify device, follow instructions for foldable screens, and manage incline/decline systems.
Specifies the deadline for implementing the corrective measures, set for January 23, 2023.
Indicates whether a client response, such as an acknowledgement of receipt, is required.
Details measures taken by the manufacturer, such as providing a reminder of instructions for use.
Determines if the Field Safety Notice (FSN) should be communicated to the patient or end user.
Clarifies if the manufacturer provided additional tailored information to patients/users.
Identifies the type of safety notification as 'New'.
States that no other advice or information is expected in the follow-up to this notification.
Provides the manufacturer's name (Médipréma) and address.
Indicates whether the competent regulatory authority in the country has been informed.
Lists any attached documents relevant to the notification, none are listed here.
Identifies the signatory as the Quality and regulatory affairs manager.
The device manual describes the infant radiant warmer for newborns FABIE (Ref. 4300) and the AMBIA care cradle (Ref. 4356 and 4357), manufactured by Médipréma. This safety notice serves as a reminder of the instructions for use for these devices, emphasizing proper handling and safety protocols to prevent incidents.
The FABIE-AMBIA radiant incubator is designed to maintain the thermal balance of a newborn by direct radiation of infrared energy. This is crucial for newborns who may struggle to regulate their body temperature independently. The device provides a controlled environment, ensuring the infant remains at an optimal temperature, which is vital for their health and development. The radiant warmer utilizes infrared energy to gently warm the infant, mimicking the warmth of a parent's embrace. This method of warming is efficient and allows for easy access to the infant for medical procedures or care. The system is designed to be user-friendly for medical professionals, allowing for quick adjustments and continuous monitoring of the infant's condition.
The AMBIA care cradle, specifically models 4356 and 4357, complements the radiant warmer by providing a secure and adjustable sleeping surface for newborns. These cradles are equipped with features that enhance infant safety and comfort, such as incline/decline systems and foldable screens. The combination of the radiant warmer and the care cradle creates a comprehensive system for neonatal care, ensuring both thermal regulation and a safe resting environment. The design prioritizes the well-being of the newborn, incorporating elements that prevent accidental falls and allow for easy observation by medical staff.
The FABIE-AMBIA devices come with several usage features designed to enhance safety and ease of operation. A key feature is the foldable screens, which are crucial for containing the infant within the sleeping surface. To fold the screens down, users must pull them slightly upwards (1) and then tilt them outwards (2). This action allows for easier access to the infant. When closing the screens, the process is reversed: fold them up (1) and ensure they go down (2) after reaching the vertical position to ensure correct locking. This locking mechanism is vital to prevent accidental opening and ensure the infant's safety. To remove the screens entirely, slide out the two hinge pins, one after the other (1), and then remove the screen (2). It is imperative to always check that all screens are properly closed and locked before leaving the newborn unsupervised, especially after any intervention. Never leave the device unattended while the screens are folded down, as this poses a significant risk of the infant falling out.
The FABIE radiant warmer also includes a bedding tray incline/decline system. The tilt position of the tray is adjusted by holding the tray with the left hand and pulling the lever located under the tray on the right with the right hand. To adjust the tilt, pull the lever completely (1) and then adjust the tilt of the tray (2) without applying excessive force. Releasing the lever (1) locks the tilt in place. It is essential that the tray pivots effortlessly when the lever is pulled. If the tray pivots with difficulty or does not lock when the lever is released, users must stop using the device immediately and contact Médipréma Customer Service. This ensures that the gas spring mechanism is functioning correctly and prevents potential hazards. The baby can slip if the tray is in a highly tilted position, and loops are provided for use with retaining straps to prevent this. Medical personnel are responsible for deciding whether or not to use these straps and must always ensure the side screens are locked to prevent falling hazards.
The AMBIA care cradle also features an incline system. To lower the bedding, push the handle toward the inside (1) and then lower the bedding (2) without applying excessive force. To raise the bedding, simply push on the handle, and a gas spring will automatically raise it. Similar to the FABIE warmer, the tray should pivot effortlessly when the handle is pushed. Users must fully push the handle to ensure the gas spring is correctly unlocked before attempting to adjust the tilt. If the tray pivots with difficulty or does not lock, the device should not be used, and Médipréma Customer Service should be contacted. The risk of the baby slipping in a maximum tilt position is also present here, and retaining straps are provided for use at the discretion of medical personnel.
The device is intended for use by suitably trained persons under the direction of qualified medical personnel. Parents or other non-medical personnel should only manipulate the device under the supervision of trained medical staff. It is crucial to ensure that the screen at the front of the sleeping surface is in the upright position and locked when the incline/decline system is activated. The child must never be left unsupervised if the screen is opened.
While the manual primarily focuses on usage and safety, it implicitly highlights aspects related to device maintenance through its emphasis on proper functioning and reporting issues. The instruction to "stop using the device and contact Médipréma Customer Service" if the tray pivots with difficulty or fails to lock serves as a critical maintenance directive. This indicates that users are not expected to perform complex repairs themselves but rather to identify malfunctions and seek professional assistance. This approach ensures that any issues are addressed by trained technicians, maintaining the device's safety and operational integrity.
The mention of "non-compliance with the instructions for use in the user manual" as a factor in incidents underscores the importance of adhering to operational guidelines, which indirectly contributes to the longevity and proper functioning of the device. Regular review of the user manual and adherence to its instructions can prevent misuse that might lead to wear and tear or damage.
Furthermore, the document states that "training sessions can be provided on request" and encourages users to contact Médipréma for user training. This proactive measure ensures that all users are proficient in operating the device, thereby minimizing the risk of damage due to improper handling. Proper training can be considered a form of preventative maintenance, as it reduces the likelihood of operational errors that could lead to device malfunction or breakdown.
The manufacturer's commitment to providing contact information for sales, after-sales services, and quality departments (service.commercial.france@mediprema.com, sav@mediprema.com, qualite@mediprema.com) indicates a robust support system for users. This accessibility allows for prompt reporting of incidents, queries regarding device functionality, and requests for service, all of which are integral to maintaining the device in optimal condition. The emphasis on reporting product-related incidents to the manufacturer, distributor, or competent authority provides valuable feedback that can inform future design improvements and maintenance protocols.
In summary, while direct "maintenance features" in terms of user-performable tasks are limited, the manual outlines a clear framework for ensuring the device's continued safe and effective operation through strict adherence to usage instructions, prompt reporting of malfunctions, and reliance on professional support for technical issues. This approach prioritizes user safety and device reliability by centralizing complex maintenance tasks with the manufacturer's qualified personnel.
General| Category | Medical Equipment |
|---|---|
| Brand | Mediprema |
| Model | AMBIA |
| Storage Conditions - Temperature | -20°C to +50°C |
| Storage Conditions - Humidity | 10% to 95% RH (non-condensing) |
