BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0939-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0939-2013
    Event ID
    64447
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    March 11, 2013
    Termination Date
    May 20, 2013
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    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.

    Code Info

    Catalog Number MS20783 (Infinity MCable-Dual Hemo)

    Distribution

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

    Quantity

    260