Events

Alerte De Sécurité sur Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter 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 Fisher & 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
    2014-04-16
  • Date de publication de l'événement
    2014-04-16
  • 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_20140416.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 infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits the australia therapeutic goods administration (tga) posted a medical device safety alert concerning infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits, manufactured by fisher & paykel healthcare ltd.(fph) the manufacturer has received customer reports relating to certain lot numbers of certain models of nasal cpap prongs detaching from the fph flexitrunk nasal tubing, especially in the presence of mucous and/or moisture. in the event of the affected prongs detaching from the nasal tubing, therapy is likely to be interrupted. this may lead to a patient becoming hypoxic. the manufacturer requests customers to identify any units form the affected lot and destroy the affected prong. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00437-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2014.

Device

Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Fisher & Paykel Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits
  • Manufacturer
    Fisher & Paykel Healthcare Ltd

Manufacturer

Fisher & Paykel Healthcare Ltd