BEUDAMED
    FDA Recall Terminated

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    Recall: Z-1440-2014 · Initiated March 5, 2014

    Recall

    Recall Number
    Z-1440-2014
    Event Number
    67677
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2014
    Posted
    April 10, 2014
    Terminated
    October 31, 2014
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    Reason

    The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.

    Action

    Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

    Distribution

    USA Nationwide Distribution in the states of WI and NY.

    Quantity

    3