Events

Alerte De Sécurité sur Single Use Home Ventilation 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 & Paykel Healthcare.

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
    2017-10-27
  • Date de publication de l'événement
    2017-10-27
  • 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_20171027b.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 & paykel healthcare single use home ventilation breathing circuit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has posted a medical device safety alert concerning single use home ventilation breathing circuit, manufactured by fisher & paykel healthcare. [reference number: rt443; lot numbers: from lot 2100089390 to lot 2100233760] the manufacturer is initiating a voluntary recall of the products due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates. a split tubing cuff on the catheter mount may potentially cause a leak, which could lead to patient hypoxaemia if undetected. users are advised to take the following actions: identify any affected products in their inventory by checking the ref and lot number on the packaging. for the affected products, disconnect the catheter mount component, cut this in half and then dispose the entire kit. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-16-to-20-october-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 october 2017.

Device

Single Use Home Ventilation Breathing Circuit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fisher & Paykel Healthcare Single Use Home Ventilation Breathing Circuit
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare