Events

Safety Alert for NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device

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

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
    2014-09-23
  • Event Date Posted
    2014-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140923.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: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning noxboxi inhaled nitric oxide delivery and monitoring device, manufactured by bedfont scientific. the manufacturer noticed that some operators of the noxboxi nitric oxide delivery and monitoring device have been using components which have not been supplied or recommended by bedfont scientific. the manufacturer has provided a list of possible components which are not supplied by bedfont scientific. in the field safety notice. these components included calibration gas, sample lines / disposables, manual bagging accessories and transportation accessories. according to the manufacturer, using such supplied parts may damage the device and cause injury or in some cases death to the patient or the operator. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con455982 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 september 2014.

Device

NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bedfont Scientific NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
  • Manufacturer
    Bedfont Scientific

Manufacturer

Bedfont Scientific