BEUDAMED
    FDA Enforcement Class II Terminated

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    Recall: Z-0399-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0399-2016
    Event ID
    70931
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Visicu, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2015
    Initiation Date
    March 27, 2015
    Classification Date
    December 10, 2015
    Termination Date
    September 23, 2016
    Address
    217 E Redwood St Ste 1900, N/A, Baltimore, MD, 21202-3315, United States

    Description

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    Reason

    A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.

    Code Info

    eCareManager v3.7, 3.7.1, v3.8, and v3.9

    Distribution

    US distribution only.

    Quantity

    43