Events

Alerta De Seguridad para MYLA SERVER HP PROLIANT - DL 380-G8 AND DI350- G6 linked to VITEK MS (registration 10158120668). The middleware is an item not registered in Anvisa.//// All the Myla middleware installed in the national territory are inserted in this field action.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomérieux Brasil SA.; bioMérieux S.A..

¿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
  • ID del evento
    1574
  • Fecha
    2015-05-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to the registry holder, the device is installed on the Vitek MS system, whose registry is 10158120668 but can also be employed as a data management middleware extracted from various devices. The problem may occur many times over the life cycle of the product. The overall risk associated with the problem is greater in version 3.X.
  • Causa
    The myla server may stop working on clients with a large volume of routine, due to the amount of data to be managed. the server stops because of a security mechanism that prevents its functionality in cases where execution takes more than 5 minutes to process.
  • Acción
    For correction the company will create a software set-up to modify the initialization phase of the MYLA to be installed by an employee of the registration holder in Brazil. The fix will maintain server performance. The company will write a letter to the owners of the Vitek MS equipment, in which the MYLA middleware is installed, stating the problem and installing the correct one.

Device

MYLA SERVER HP PROLIANT - DL 380-G8 AND DI350- G6 linked to VITEK MS (registration 10158120668). ...

Manufacturer

Biomérieux Brasil SA.; bioMérieux S.A.