Events

Alerte De Sécurité sur NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Bedfont Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-09-23
  • Date de publication de l'événement
    2014-09-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140923.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bedfont Scientific NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
  • Manufacturer
    Bedfont Scientific

Manufacturer

Bedfont Scientific