Events

Alerte De Sécurité sur Arkon Anesthesia Delivery System

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
    2015-09-29
  • Date de publication de l'événement
    2015-09-29
  • 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_20150929d.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 arkon anesthesia delivery system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning arkon anesthesia delivery system [model number: 99999 (230 vac versions)], manufactured by spacelabs healthcare. the manufacturer has received two reports of the arkon transformer inrush pcba (pn: 670-1624-00) failing prematurely and causing loss of power on all auxiliary power outlets. the failure mode requires the cumulative auxiliary power outlet load to be in excess of 200 watts. if the inrush pcba fails, anesthesia monitoring, alarming and ventilation delivery will not be affected. according to the manufacturer, the potential risk is that devices which do not have battery backup and that are plugged into an auxiliary outlet may lose power. the manufacturer advises affected users to weigh the benefits versus the risks as well as ability to deploy alternative devices when deciding whether or not to continue to use the system. if users continue to use the affected system, the manufacturer advises the following: keep the total load on the arkon auxiliary outlets below 200 watts cumulatively. if the cumulative load exceeds 200 watts, plug the device(s) into another supply such as provided in the wall outlets. the manufacturer would replace the affected transformer inrush pcba. for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-21-to-25-september-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 september 2015.

Device

Arkon Anesthesia Delivery System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Spacelabs Healthcare Arkon Anesthesia Delivery System
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare