Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts; Nurse Managers, Labor & Delivery/NICU, Bio-Medical Engineering Department Managers and Risk Management Directors We will track all service requests for the field action to completion. These service requests will record the replacement of the affected Power Cords. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures.