Events

Recall of Mindray DPM 6 and DPM 7 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
    69788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0837-2015
  • Event Initiated Date
    2014-10-06
  • Event Date Posted
    2014-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131541
  • 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 that involves the ibp module used with the dpm 6 and dpm 7 monitor where the ibp measurement data may be displayed in an incorrect ibp tile on the monitors display.
  • Action
    Mindray DS USA, Inc. sent an Urgent Field Corrective Action Letter dated 10/6/2014 to their customers via certified mail with return receipt. The letter identified the affected product, the problem, adverse effects on the patient, and corrective actions. Customers are asked to either verify that the IBP modules are not affected by following the steps provided in the "Procedures for Verifying IBP Channel Connections;" or to discontinue use of the IBP modules until a Mindray Service Representative contacts them and performs the test to verify the function of the IBP modules. Customers are to contact their local Mindray Service Representative at 1-800-288-2121 to inform them of which corrective action will be taken. Questions should be directed to Diane Arpino at 201-995-8407 or d.arpino@mindray.com.

Device

Mindray DPM 6 and DPM 7 Monitor
  • Model / Serial
    DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00, IBP Module P/N: 6800-30-50485
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
  • Product Description
    DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . || Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America