BEUDAMED
    FDA Recall Terminated

    AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 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-0319-2009 · Initiated October 7, 2008

    Recall

    Recall Number
    Z-0319-2009
    Event Number
    49713
    Firm
    Mindray DS USA, Inc., dba Datascope Patient Monitoring
    FEI Number
    2221819
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 7, 2008
    Posted
    December 5, 2008
    Terminated
    December 8, 2008
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430

    Description

    AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

    Reason

    Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate

    Action

    Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.

    Distribution

    Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.

    Quantity

    2 units