Events

Recall of 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. d.b.a. 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
    63614
  • Event Risk Class
    Class 2
  • Event Number
    Z-0513-2013
  • Event Initiated Date
    2010-08-11
  • Event Date Posted
    2012-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114364
  • 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
    There is an issue with the dpm 6 and dpm 7 monitors where the following features may be unavailable : full disclosure, drug, hemodynamic calculations, renal calculations, oxygenation calculations, and ventilation calculations.
  • Action
    Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue.

Device

Mindray DS USA Inc.
  • Model / Serial
    K092449  DPM 6- p/n 6802F-PA00001  DPM 7 - p/n 6800F-PA00001
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
  • Product Description
    DPM 6/7 Patient Monitor || Manufactured in China for : || Mindray DS USA, Inc. || 800 MacArthur Blvd. || Mahwah, NJ 07430 USA. || Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
  • Manufacturer
    Mindray DS USA, Inc. d.b.a. Mindray North America

Manufacturer

Mindray DS USA, Inc. d.b.a. Mindray North America