Events

Recall of V Series Monitor, Mindray DS USA, Inc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. dba Mindray North America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66755
  • Event Risk Class
    Class 2
  • Event Number
    Z-0389-2014
  • Event Initiated Date
    2013-10-07
  • Event Date Posted
    2013-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123285
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Mindray has identified an issue with v series monitor where the v dock power pins connecting the v series monitor to the v dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. no patient related events have been reported to mindray concerning the issue.
  • Action
    Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product.

Device

V Series Monitor, Mindray DS USA, Inc
  • Model / Serial
    V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) || Product Usage: || The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America