BEUDAMED
    FDA Recall Terminated

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    Recall: Z-0939-2013 · Initiated December 13, 2012

    Recall

    Recall Number
    Z-0939-2013
    Event Number
    64447
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 13, 2012
    Posted
    March 11, 2013
    Terminated
    May 20, 2013
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    Reason

    The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.

    Action

    Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.

    Distribution

    Distributed in the states of CA, IL, and MA.

    Quantity

    260