BEUDAMED
    FDA Recall Terminated

    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

    Recall: Z-0798-2013 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-0798-2013
    Event Number
    64114
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 28, 2012
    Posted
    February 11, 2013
    Terminated
    August 15, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

    Reason

    Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.

    Action

    Mindray North America/ Mindray DS USA Inc. sent an "URGENT PRODUCT CORRECTION ACTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your Mindray Service Representative at 1-800-288-2121 for questions relating to this issue.

    Distribution

    Nationwide Distribution.

    Quantity

    51 units