Events

Recall of Device Recall Mindray DS USA Inc. DPM 6 Monitor.

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
    67932
  • Event Risk Class
    Class 2
  • Event Number
    Z-1611-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-05-13
  • 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=126625
  • 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
    The mpm included a cardiac st/arrhythmia analysis feature which is not cleared for marketing.
  • Action
    Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.

Device

Device Recall Mindray DS USA Inc. DPM 6 Monitor.
  • Model / Serial
    monitor p/n 6802F-PA00001  module p/n 115-001704-00/M51A-30-80876
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the state of OH
  • Product Description
    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, 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. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America