Events

Safety Alert for V series patient monitors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Mindray.

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
  • Date
    2011-11-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111122.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Mhra field safety notice: mindray v series patient monitor the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that a software anomaly contained in the v series monitor manufactured by mindray. according to the manufacturer, in rare instances, a system database corruption may occur that may cause the v series monitor to reset. the system will return to monitoring after 90 seconds, however, the database corruption may persist. should the database corruption persist, established patient settings may be incorrect and established alarm settings, including those related to arrhythmias, may be incorrect or not available. patient data may not be displayed or only partially displayed. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.

Device

V series patient monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Mindray V series patient monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray