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
    2013-12-11
  • Date de publication de l'événement
    2013-12-11
  • 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_20131211.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 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
  • 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