BEUDAMED
    FDA Recall Terminated

    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    Recall: Z-0291-2013 · Initiated August 13, 2012

    Recall

    Recall Number
    Z-0291-2013
    Event Number
    63314
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 13, 2012
    Posted
    November 16, 2012
    Terminated
    June 4, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    Reason

    Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.

    Action

    The firm, Mindray DS USA Inc., sent an "URGENT: A3/A5 ANESTHESIA DELIVERY SYSTEM CORRECTIVE ACTION" letter dated August 13, 2012 to their customers via Certified Mail return receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to route this letter to all potential uses of the product within their facility; increase fresh gas flow, should the leak occur during use, to compensate for any pressure loss resulting from the leak; alternatively, the absorber canister may be unlocked and locked again to reseat the gasket and verify that the canister and gasket are fully seated, a leak test is performed after replacement of the Pre-Pak or loose-fill absorbent and also be performed before each patient use until the canister gaskets are replaced on systems in their facility. A Mindray Representative will replace the canister gasket to correct the issue. If you have any questions or need to arrange for a replacement of the absorber canister gasket on the A3/A5 System(s) in your facility, contact your Mindray Service Representative, at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm). A press release was issued by the firm on 11/14/2012.

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.

    Quantity

    346 units (311 US - 35 Foreign)