Events

Recall of T1 Patient 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
    77390
  • Event Risk Class
    Class 2
  • Event Number
    Z-2634-2017
  • Event Initiated Date
    2017-04-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155916
  • 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 received two reports from outside the united states that the battery pack for ti transport monitor/module overheated.
  • Action
    Mindray notified their customers on April 28, 2017.Customers are provided information regarding this correction. Once the customer has identified the batteries, the customer should contact Mindray Customer Service to arrange for the no charge delivery of replacements. Mindray Customer Service representatives may be reached at (800) 288-2121 (Option 3), Monday through Friday 8:30 amd -5:30 pm, ET.

Device

T1 Patient Monitor
  • Model / Serial
    two sales brochures: p/n: 0002-08-30034 and 0002-08-30035  two copies of labels: 047-014270-00, 047-010964-00, 047-018754-00  two copies of operator's manuals: 115-040812-00 and TNC 14-FZ007-F-001
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    TI Transport Monitor/Module Battery Pack || Product Usage: || intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America