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
    2013-12-11
  • Event Date Posted
    2013-12-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131211.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 has posted a medical device safety alert concerning noxboxi inhaled nitric oxide delivery and monitoring device , manufactured by bedfont scientific ltd. the affected serial numbers are identified as follows: ni100004, ni100006, ni100009, ni100010, ni100011, ni10012, ni100013, ni100014, ni100015, ni100016, ni100017, ni100018, ni100019, ni100020, ni100022, ni100024, ni100025, ni100027, ni100028, ni100029, ni100030, ni100031, ni100032, ni100034, ni100035, ni100036, ni100037, ni100038, ni100039, ni100040, ni100042, ni100043, ni100044, ni100045, ni100046, ni100047, ni100048, ni100049, ni100050, ni100051, ni100052, ni100053, ni100054, ni100055 ni100056, ni100057, ni100058, ni100059, ni100060, ni100061, ni100062, ni100064, ni100065, ni100066, ni100067, ni100071, ni100072, ni100073, ni100074, ni100075, ni100076, ni100077, ni100079 according to the manufacturer, a fault has been identified within the noxboxi firmware, whereby after 6 days of continuous use the screen may freeze/lock and will not respond. after another unknown period of hours this may cause the system to crash and enter “safe” mode, at this point delivery of nitric oxide (no) therapy is stopped. if the patient is dependent on inhaled nitric oxide, this failure could result in serious injury or death of the patient. the manufacturer advises users not to use the noxboxi continuously for a period longer than 6 days until a firmware upgrade is implemented on the device. a firmware fix has been released to prevent this fault from occurring (0.0.12.1), which users must install on their device immediately. if the device already has this firmware version installed no action is required. for details, please visit the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con341279 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2013.

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