BEUDAMED
    FDA Enforcement Class II Terminated

    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    Recall: Z-2059-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2059-2014
    Event ID
    68582
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    May 19, 2014
    Classification Date
    July 16, 2014
    Termination Date
    April 20, 2017
    Address
    800 MacArthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    Reason

    ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.

    Code Info

    Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.

    Distribution

    Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.

    Quantity

    113 units (57 United States; 56 International)