GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential Reversal of Oxygen/Air

AUDIENCE: Risk Managers, Pulmonology

ISSUE: The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.

This product may cause serious adverse health consequences, including death.

BACKGROUND:  The Giraffe and Panda T-Piece Resuscitation Systems and the Giraffe Panda Bag and Mask Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants. On October 15, 2012, GE Healthcare sent its affected customers an "Urgent Medical Device Correction" letter with a return receipt. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction.

RECOMMENDATION:

• It is recommended that a qualified biomedical technician or respiratory therapist identify the affected resuscitation system and locate the air and oxygen fittings and labels at the back of the unit. With the table provided, identify the appropriate fitting for their country and location and verify the air fitting is located on the left side and the oxygen fitting is located on the right.
• Verify the air label is located on the left side and the oxygen label is on the right. Verify that the color of the air and oxygen labels match the picture on the table provided.
• If the unit does not meet all of the criteria, the unit will require repair.
• If the unit is in use with the patient, disconnect the wall supply gas and switch to a tank supply. Once the patient no longer requires respiratory support, transfer the patient to another bed and remove the unit from service. A Field Engineer will be deployed to your site to complete the required repair.
• If the unit is NOT in use with the patient, take the unit out of service. A Field Engineer will be deployed to your site to complete the required repair

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339884.htm