Events

Alerte De Sécurité sur Anesthesia Workstations and Service 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 Spacelabs Medical.

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
    2013-03-27
  • Date de publication de l'événement
    2013-03-27
  • 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_20130327a.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: spacelabs anesthesia workstations and service kits the u.S. food and drug administration (fda) posted a medical device safety alert concerning bleasesirius anesthesia workstation, bleasefocus anesthesia workstation, and cas i/ii absorber contained in service kits part number 12200902, 050-0659-00, and 050-0901-00, and any workstation installed with the cas i/ii absorber, manufactured by spacelabs medical. these products were manufactured and distributed from 31 oct 2012 to 15 jan 2013. there is a defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. until spacelabs replaces the affected product, the manufacturer advises customers to: immediately cease use of bleasesirius and bleasefocus anesthesia workstations shipped after 31 oct 2012. immediately cease use of service kits part number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a cas i/ii absorber from a service kit. for details, please refer to fda websites http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm345368.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm345346.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 march 2013.

Device

Anesthesia Workstations and Service Kits
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Spacelabs Anesthesia Workstations and Service Kits
  • Manufacturer
    Spacelabs Medical

Manufacturer

Spacelabs Medical