Events

Alerte De Sécurité sur CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations

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 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
    2013-11-28
  • Date de publication de l'événement
    2013-11-28
  • 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_20131128.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 healthcare cas i/ii absorbers installed in the bleasesirius and bleasefocus anesthesia workstations the united states food and drug administration (fda) has issued a medical device safety alert concerning the recall of cas i/ii absorbers installed in the bleasesirius and bleasefocus anesthesia workstations, manufactured by spacelabs healthcare. the affected products are identified as follows: part no.: 12200900, 12200901, 12200902, 12200903, 14200100 service kits part number: 050-0659-00 and 050-0901-00 manufacturing date: 21 feb 2013 through 30 sep 2013 due to a potential defect in the affected products, the bag to-vent switch in cas i/ii absorbers may fail due to loose fastening hardware in an absorber. in the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. operation in vent mode along with all monitoring and alarm functions will continue to operate normally. customers with questions were advised to contact spacelabs healthcare for technical support. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm376772.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm376764.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 november 2013.

Device

CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Spacelabs Healthcare CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare