Events

Alerte De Sécurité sur nFlow Infant Nasal CPAP Breathing System

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

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
    2014-10-14
  • Date de publication de l'événement
    2014-10-14
  • 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_20141014b.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: intersurgical nflow infant nasal cpap breathing system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning nflow infant nasal cpap breathing system, manufactured by intersurgical. the affected ref numbers were 4700000, 4700001, 4700003, 4700004, 4700006, 4700007, 4700008, 4700009, 4700010, 4700014, 4700016, 4700017, 4700020, 4700150, 4760000 and 4761000. the affected lot numbers were from 31400042 till 31458271. there is a small possibility that the inspiratory tube or monitoring line tube may detach from the nflow generator. this will result in loss of ventilation or its monitoring. the manufacturer advises affected users to quarantine and destroy the above lot numbers. alternatively if the products are required urgently, users are advised to inspect the product to make sure there is a noticeable amount of glue where the tube goes into the generator (patient end connector). furthermore, users are advised to monitor the system continuously during use. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 october 2014.

Device

nFlow Infant Nasal CPAP Breathing System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Intersurgical nFlow Infant Nasal CPAP Breathing System
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical