BEUDAMED
    FDA Enforcement Class II Ongoing

    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

    Recall: Z-2949-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2949-2024
    Event ID
    95099
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2024
    Initiation Date
    July 22, 2024
    Classification Date
    September 4, 2024
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

    Reason

    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. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

    Code Info

    UDI-DI: 06936415975784 Serial Number: AH6D28000517, AH6D28000518

    Distribution

    US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada

    Quantity

    2 units