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 DS USA.

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
    2012-06-19
  • Event Date Posted
    2012-06-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120619.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
    Medical device safety alert: mindray v series patient monitors the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the v series monitor, manufactured by mindray ds usa, incorporation. the manufacturer has identified two software anomalies contained in the v series monitoring system. these anomalies occur only when a vps module is connected to v12 or v21 monitor that has been monitoring a patient of a different size than the one used by the vps module. when a vps module is inserted into a v12 or v21 monitor, the two components can be synchronized so they use either the vps or the monitor settings. the two software anomalies can be summarized as follow:- a software anomaly causing the non invasive blood pressure inflation pressure and arrhythmia algorithm settings to operate based on the settings associated with the patient size previously used on the monitor instead of using the settings associated with the patient size imported from the vps. a software anomaly causing the system to utilize incorrect departmental defaults. the manufacturer advised that vps modules should not be used between systems until the software upgrade has been completed. 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 contact your supplier for necessary actions. posted on 19 june 2012.

Device

V Series Patient Monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Mindray V Series Patient Monitors
  • Manufacturer
    Mindray DS USA

Manufacturer

Mindray DS USA