Events

Recall of Device Recall Mindray 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
    71934
  • Event Risk Class
    Class 2
  • Event Number
    Z-2737-2015
  • Event Initiated Date
    2015-07-27
  • Event Date Posted
    2015-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139403
  • 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 dpm 7 monitors may display a black screen.
  • Action
    Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.

Device

Device Recall Mindray DPM 7 Monitor
  • Model / Serial
    Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
  • Product Description
    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) || Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America