BEUDAMED
    FDA Recall Terminated

    DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.

    Recall: Z-0837-2015 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0837-2015
    Event Number
    69788
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 6, 2014
    Posted
    December 19, 2014
    Terminated
    June 6, 2017
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.

    Reason

    Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.

    Action

    Mindray DS USA, Inc. sent an Urgent Field Corrective Action Letter dated 10/6/2014 to their customers via certified mail with return receipt. The letter identified the affected product, the problem, adverse effects on the patient, and corrective actions. Customers are asked to either verify that the IBP modules are not affected by following the steps provided in the "Procedures for Verifying IBP Channel Connections;" or to discontinue use of the IBP modules until a Mindray Service Representative contacts them and performs the test to verify the function of the IBP modules. Customers are to contact their local Mindray Service Representative at 1-800-288-2121 to inform them of which corrective action will be taken. Questions should be directed to Diane Arpino at 201-995-8407 or [email protected].

    Distribution

    Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.

    Quantity

    455 units