miércoles, 9 de mayo de 2018

FDA MedWatch - Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error

U.S. Food and Drug Administration Header
Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error
AUDIENCE: Anesthesiology, Risk Manager, Surgery

ISSUE: Dräger Medical is recalling the Fabius Anesthesia machines due to excessive oil that was not removed at the time of production. Such excess oil may interfere with the position detector of the ventilation motor during operation and may cause ventilation to fail. A halt in ventilation may lead to serious adverse health consequences, including patient injury or death.
Model/Item Numbers: See complete lists for Fabius GS PremiumFabius TiroFabius Tiro MFabius MRI Anesthesia Machines
Devices Recalled in the U.S.: 62 units in Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and Puerto Rico.

BACKGROUND: The Fabius Anesthesia machines are inhalation anesthesia machines for use in operating, induction and recovery rooms at hospitals and at Magnetic Resonance Imaging (MRI) settings with patients of all ages. They may be used with oxygen (O2), nitrous oxide (N2O), and air supplied by a medical gas pipeline system or by externally mounted gas cylinders.

RECOMMENDATION:  Dräger Medical sent an Urgent Medial Device Recall notification letter on March 1, 2018, instructing customers to continue to operate the devices with the usual attention and to ensure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use.

The company is producing replacement motors and a service representative will contact affected customers to arrange appointments for replacing the motor free of charge.
Customers who want more information about the March 1, 2018, Urgent Medial Device Recall notification letter may call Dräger Medical from 8:00 am to 4:30 pm Eastern Standard Time at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and servicing of the Fabius Anesthesia machines, please contact the Dräger Service Technical Support between the hours of 8:00 am to 8:00 pm Eastern Standard Time at 1-800-437-2437 (press 4 at the prompt then 4 again).
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
  • 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 MedWatch Safety Alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607182.htm

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