BEUDAMED
    FDA Enforcement Class II Terminated

    Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    Recall: Z-0389-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0389-2014
    Event ID
    66755
    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
    December 4, 2013
    Initiation Date
    October 7, 2013
    Classification Date
    November 25, 2013
    Termination Date
    April 27, 2015
    Address
    800 MacArthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    Reason

    Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.

    Code Info

    V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    1839 units