BEUDAMED
    FDA Recall Terminated

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), 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-0513-2013 · Initiated August 11, 2010

    Recall

    Recall Number
    Z-0513-2013
    Event Number
    63614
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 11, 2010
    Posted
    December 11, 2012
    Terminated
    August 2, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), 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

    There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.

    Action

    Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.

    Quantity

    124 units