Early Alert for GE HealthCare Infant Resuscitation Systems

GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use, according to an FDA alert.

GE HealthCare’s Integrated Resuscitation and Standalone Infant Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures during manual ventilation to the infant, according to the FDA.

According to an FDA early alert, GE HealthCare has found that the air-oxygen blender knob shaft on certain integrated and stand-alone resuscitation systems can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient, the FDA warns.

As of May 20, GE HealthCare has not reported any serious injuries or deaths associated with this issue.

Affected Devices

FDA Recommendations

Identify and remove affected devices from use until they can be corrected. If affected devices must be used prior to correction, follow the additional precautions below.

On May 8, GE HealthCare sent all affected customers a letter recommending the following actions:

• Inspect all Giraffe and Panda Warmers with Integrated Resuscitation System (iRes) and Giraffe Stand-alone Infant Resuscitation System devices to determine if the device has an affected blender. 
• If the device has an affected blender, remove the unit from patient use and contact a GE HealthCare Service Representative at the number listed below. 
• If a device with an affected blender must be used prior to being corrected by GE HealthCare, follow the instructions below:
  • Follow the instructions in the device User Manuals, including all pre-use checkout instructions. These manuals also include the following requirements and warnings:
    • Pre-use checkout: Before each operation, inspect the resuscitation system for damage, such as broken knobs and fittings or gauges with indicator needles that are not at 0. 
    • Do not do the pre-use checkout procedure, service, or calibrate the device with the patient in the device. Make sure all pre-use checkout procedure steps are correctly completed before each patient use. If a step fails, do not use the device. 
  • Perform the blender Multipoint Oxygen Concentration Check as described in Section 2.5.1 of the Service Manual M1128929. 
  • If the pre-use checkout passes and the Multipoint Oxygen Concentration Check meets specifications, GE HealthCare recommends oxygen concentration should be verified with an independent oxygen analyzer on a frequent basis until the unit is corrected. 
  • If the pre-use check does not pass (e.g., the blender knob is loose) or the Multipoint Oxygen Concentration Check does not meet specifications, remove the unit from patient use. 
  • Note: User and service manuals are available on the Customer Documentation Portal: https://www.gehealthcare.com/support/manualsExternal Link Disclaimer
• Evaluate existing service stock for affected blenders. The blender model number and serial number are visible on the packaging. The serial number is visible on the blender. Quarantine any affected blenders.

For more information, read the FDA alert.