Alerta De Seguridad para Maquet Cardiovascular Flow-i Anaesthesia System

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: maquet cardiovascular flow-i anaesthesia system the united states food and drug administration (fda) has issued an alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular. [model numbers: c20 (for united states), c30 and c40; part numbers: 66 77 200 (united states only), 66 77 300 and 66 77 400; serial numbers: 2743, 2852, 2854, 2855, 2856, 2858] according to the manufacturer, the system is intended for use on neonatal to adult patient populations in hospital environments, except mri environment by healthcare professionals trained in inhalation anesthesia administration. electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0804-2016&w=03022016&lang=eng posted on 7 march 2016.