BEUDAMED
    FDA Enforcement Class II Terminated

    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

    Recall: Z-0170-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0170-2019
    Event ID
    81084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 30, 2018
    Classification Date
    October 17, 2018
    Termination Date
    December 20, 2018
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

    Reason

    The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.

    Code Info

    This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00

    Distribution

    Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.

    Quantity

    5