Events

Safety Alert for Graseby MR10 Neonatal Respiration Monitor

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

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
    2011-12-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111213.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
    Field safety notice: smiths medical graseby mr10 neonatal respiration monitor the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice advising users of a voluntary correction of a limited number of graseby mr10 neonatal respiration monitors. medical device manufacturer, smiths medical, has identified that the three battery straps in the mr10 battery box can become permanently deformed, causing the batteries to make only intermittent contact. if this condition occurs during use, then the mr10 may stop functioning without producing an audible alarm. if this condition occurs during an apnoea event, and if it is not observed that the indicator light is no longer lit, this could result in serious injury or death. 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 product, please contact your supplier for necessary actions.

Device

Graseby MR10 Neonatal Respiration Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smiths Medical Graseby MR10 Neonatal Respiration Monitor
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical