BEUDAMED
    FDA Enforcement Class II Terminated

    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)

    Recall: Z-1611-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1611-2014
    Event ID
    67932
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 21, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    May 12, 2014
    Termination Date
    April 27, 2015
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)

    Reason

    The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

    Code Info

    monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876

    Distribution

    US Nationwide Distribution in the state of OH

    Quantity

    4 units