Events

Safety Alert for T series patient monitor and anesthesia machines Series A Mindray

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1609-383
  • Event Number
    2009EBC-0003486 ; 2008EBC-0002391 ; 2013EBC-0010712
  • Date
    2016-09-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified a possible problem with a leak in the referenced water traps, which could potentially lead to erroneous monitoring of co2 and / or anesthetic gases causing an incorrect treatment, leading to possible adverse events in patients.

Device

T series patient monitor and anesthesia machines Series A Mindray
  • Model / Serial
    water traps reference DRYLINE II, lots 1537, 1538, 1541, 1545, 1547, 1548, 1602 and 1606.
  • Product Description
    Indicated for monitoring vital parameters of adult, pediatric and neonatal patients during their stay at the clinic. It is used in intensive care, intermediate care unit, surgery rooms, observation and postoperative units.
  • Manufacturer
    Shenzhen Mindray Bio-Medical Electronics Co.,Ltd

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co.,Ltd