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CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation
AUDIENCE: Anesthesiology, Risk Manager
ISSUE: Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation and oxygenation.
BACKGROUND: The voluntary corrective action was issued after receiving customer complaints and product returns; upon further inspection the returned absorbers were found to leak due to a hole in the drain tube. The affected product number is M1173310 containing lot numbers 12001 through 13031. Not affected are products with lot numbers 13032 and higher.
RECOMMENDATION: Vital Signs is following up with all customers and will replace all affected units at no cost to customers. For additional information regarding this corrective action, please contact Customer Service (domestic) at 800-345-2700 (option 2 followed by option 2) if you have any questions or concerns. You may also contact International Customer Service at +1-800-932-0760 (option 2). Hours of Operation: Monday to Friday from 8:00 am EST to 5:00 pm EST.
Healthcare professionals 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 links to the Recall Notice and Product Photo at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380134.htm
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