Events

Alerte De Sécurité sur Reusable latex breathing bags

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

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
    2014-03-11
  • Date de publication de l'événement
    2014-03-11
  • 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_20140311a.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: draeger reusable latex breathing bags medical device manufacturer, draeger, has issued a field safety notice concerning its reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, 2165708, 2165716, 2165724, 2165763, 2165775 and 2165783,as part of test lung with part number 8403201, and as part of reusable anaesthesia sets with part numbers m33681, m27542, m34822, m34823 and m34824. the manufacturer became aware of an incident where a user suffered an acute allergic reaction after using a drager latex test lung. during investigation of this incident, the manufacturer discovered that the breathing bag that belongs to the test lung and other latex breathing bags are labelled nr, which is the abbreviation for natural rubber (latex). however, the labelling does not comply with the applicable international standards for medical devices. drager breathing bags made of latex (blue) are distinguishable from the latex-free version made of silicone (transparent) by their colour. the test lung with part number 8403201 and the breathing bags in the reusable anaesthesia sets with part numbers m33681 and m27542 have been switched to the latex-free version made of silicone. the manufacturer reminds users that the blue reusable breathing bags bearing the marking “nr’ do contain natural rubber (latex) and latex products can cause allergic reactions. furthermore, the manufacturer is currently working on improved labelling on the products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 march 2014.

Device

Reusable latex breathing bags
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Reusable latex breathing bags
  • Manufacturer
    Draeger

Manufacturer

Draeger