TOPIC: Flow-c and Flow-e Anesthesia Systems by Getinge USA Sales: Class I Recall – Due to Cracked or Broken Suction System Power Switches
AUDIENCE: Patient, Health Professional, Risk Manager, Anesthesiology
ISSUE: Getinge is recalling the Flow-c and Flow-e Anesthesia Systems after receiving reports of cracked or broken on/off switches on the system’s suction unit. If the on/off switch breaks, the suction unit will not work to remove fluids such as phlegm, blood, or stomach (gastric) content from the patient’s mouth and/or airways.
This issue could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. Additionally, if the suction device is not working for a longer period of time, these fluids could block a patient’s breathing. The risks of such a blockage may include:
There have been 21 complaints, no injuries and no deaths associated with the use of this device.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: The Getinge Flow-c and Flow-e Anesthesia Systems are intended to provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe.
RECOMMENDATIONS: On May 2, 2022, Getinge USA Sales sent a Medical Device Correction letter to risk managers. The letter recommended that all customers:
Health 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:
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