Events

Alerta De Seguridad para Arkon Anesthesia Delivery System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Spacelabs Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-09-29
  • Fecha de publicación del evento
    2015-09-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150929d.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Spacelabs Healthcare Arkon Anesthesia Delivery System
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare