Events

Alerte De Sécurité sur Ondal AC2000 Spring-Loaded Arm

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
    2014-04-01
  • Date de publication de l'événement
    2014-04-01
  • 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_20140401.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 ondal ac2000 spring-loaded arm the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ondal ac2000 spring-loaded arm, manufactured by draeger and up until the end of 2006. the affected part numbers are g19051, g19262, g93358 and g93359. the manufacturer has received case reports where a welded seam in the spring-loaded arm of the monitor holder broke. investigations revealed that the welded seam in the spring-loaded arm was unable in isolated cases to withstand the dynamic stress over years where monitors were frequently moved. the monitor is then at risk of falling. although no injury was reported, the risk of injury to persons positioned beneath the monitor cannot be excluded. the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394667 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 01 april 2014.

Device

Ondal AC2000 Spring-Loaded Arm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Ondal AC2000 Spring-Loaded Arm
  • Manufacturer
    Draeger

Manufacturer

Draeger