Events

Alerte De Sécurité sur Life Humidification Chamber & Heated Breathing Circuit Kits

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

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
    2018-01-31
  • Date de publication de l'événement
    2018-01-31
  • 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_20180131a.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: vyaire medical air life humidification chamber & heated breathing circuit kits the united states food and drug administration (fda) is issuing a medical device safety alert regarding the air life humidification chamber & heated breathing circuit kits, manufactured by vyaire medical. the affected devices are identified as the following: - air life humidification chamber & heated breathing circuit kits lot codes: ah290, ah132, ah265, ah202, and ah280 manufacturing dates: 18 may 2017 to 28 september 2017 distribution dates: 3 july 2017 to 10 november 2017 according to the fda, the manufacturer is recalling the airlife humidification chamber and heated breathing circuit kits due to a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit. if this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death. the manufacturer sent an urgent recall notification letter instructing affected users to: inspect inventory on-hand and remove affected lots of the airlife humidification chamber and heated breathing circuit kits destroy all affected product(s) in-stock in accordance with their facility's destruction protocol for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm594566.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 january 2018.

Device

Life Humidification Chamber & Heated Breathing Circuit Kits
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Vyaire Medical Air Life Humidification Chamber & Heated Breathing Circuit Kits
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical