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
    2014-05-07
  • Event Date Posted
    2014-05-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140507a.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. a conflict has been identified between the noxboxi regulators output and the cylinder status symbols shown on-screen. due to tolerances on the regulator output, some units may show a cylinder status as empty (red) when in fact they are full and some may show as full (green) when they are empty. with the latter a cylinder could empty without the operators knowledge, the system will switch over to the auxiliary/back-up cylinder, however when that is exhausted and system would then alarm “supply critical”. if another supply of gas is not available, sudden cessation of the therapy could occur. for patients dependent on this therapy, this failure could result in serious injury or death of the patient. the manufacturer advises affected users not to use the cylinder status icons on screen to determine gas supply. furthermore, the manufacturer is evaluating a firmware fix whereby the cylinder status tolerances are widened in order to eradicate the risk of cylinders showing as empty when they are full and full when they are empty. the regulators have a gas pressure gauge built into them which shows the cylinder status and this must be used only until a firmware fix is validated. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con409264 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 07 may 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