BEUDAMED
    FDA Recall Terminated

    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

    Recall: Z-2737-2015 · Initiated July 27, 2015

    Recall

    Recall Number
    Z-2737-2015
    Event Number
    71934
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 27, 2015
    Posted
    September 4, 2015
    Terminated
    May 2, 2017
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

    Reason

    The DPM 7 Monitors may display a black screen.

    Action

    Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.

    Distribution

    Distributed to the states of CT, IA, KY, MS, PA, UT and WA.

    Quantity

    13 units