Ohio Infant Warmer System

• • Terminated Z-2323-2017 FDA Class II ·initiated 5 May 2017

  GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

510(k) Number

K921766 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the Ohio Infant Warmer System used for?

  The Ohio Infant Warmer System is designed to provide a controlled source of radiant heat for infants and pediatric patients. It supports both manual and servo modes of operation via a microprocessor-based control system, allowing clinicians to maintain appropriate thermal regulation in general hospital settings under trained staff supervision.

• Is the Ohio Infant Warmer System a single-use or reusable device?

  The Ohio Infant Warmer System is supplied as a reusable system, meaning it is intended for repeated use after proper cleaning and maintenance. It is not designated as single-use, and regular maintenance is required to ensure safe and effective operation over time.

• Is the Ohio Infant Warmer System sterile when supplied?

  The device is not described as sterile in the provided data. Since it is a reusable radiant warmer system that requires regular maintenance, it is not supplied in a sterile condition and should be prepared according to manufacturer guidelines before each use.

• What are the storage and handling requirements for the Ohio Infant Warmer System?

  Storage and handling of the Ohio Infant Warmer System should follow the manufacturer’s guidelines to ensure device integrity and performance. Specific storage conditions are not detailed in the provided data, but users must adhere to the instructions provided by Ohmeda Medical for proper storage between uses.

• What regulatory pathway was used for the Ohio Infant Warmer System?

  The Ohio Infant Warmer System received authorization through the FDA 510(k) process, as indicated by the FDA_510K designation in the device data. The decision was classified as 'Substantially Equivalent' (SESE) to a legally marketed predicate device, with a traditional clearance type granted on April 23, 1993.