Events

Alerte De Sécurité sur Reusable Breathing Circuit

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

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
    2013-01-08
  • Date de publication de l'événement
    2013-01-08
  • 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_20130108.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: fisher and paykel reusable breathing circuit the united states food and drug administration has issued a medical device safety alert concerning reusable breathing circuit [model no.: 900mr068 & lot no.: 110810 & 111020], manufactured by fisher and paykel healthcare ltd. according to the manufacturer, the tubes used in the reusable breathing circuit have pinholes. if these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. usage of the defective device may result in patient death. customers were instructed to examine their inventory and destroy and discard any affected circuits in possession. replacement circuits will be provided to customers. according to the local supplier, the affected products were not distributed in hong kong. for further details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm334446.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm334297.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 january 2013.

Device

Reusable Breathing Circuit

Manufacturer

Fisher and Paykel Healthcare Ltd