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Health Canada Medical devices

Sevoflurane, Desflurane, and Isoflurane Electronic Vaporizer Material Package

Issued November 15, 2024
Issue
The anesthesia system is a device used to administer a general inhalation anesthetic continuously or intermittently to a patient and maintain their ventilation. The A9 anesthesia system utilizes electronic vaporizers (V90) for anesthetic agent delivery. Mindray has become aware of a potential issue with select batches of V90 electronic vaporizers. The V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 anesthesia system will generate alarms associated with abnormal vaporizer output. We recommend that the user use the part number reference to identify the license and the device identifier. Recall start date: July 22, 2024
Hazard description
Performance
Product
Product name
Sevoflurane, Desflurane, and Isoflurane Electronic Vaporizer Material Package
Reference
ID
RA-75948