Events

Alerta De Seguridad para Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 10234230180. Lots: 4021; 5016; 5030; 5094; 5101; 5107; 5126; 5147; 5188; 5191; 6016; 6035; 6038; 6055.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda..

¿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
    1703
  • Fecha
    2015-10-23
  • 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
    The company informs that if the MODULARIS system display hangs, there is a possibility that this will result in insufficient information for the treatment.
  • Causa
    Siemens healthcare has identified that on rare occasions, the modularis manual control display locks up and the information displayed on it is not updated. neither the amount of shock waves applied nor other parameters that have been changed by the user in the manual control will be displayed. this may result in insufficient information for treatment.
  • Acción
    The company advises that whenever changes in parameters are made in the manual control of the MODULARIS, the user must make sure that the display is showing the new updated values. If the MODULARIS manual control display locks, stop the treatment immediately. Currently, the potential malfunction of the incorrect treatment data display can only be mitigated by the user when the user checks that the manual control display is showing the new values ​​updated after the parameters have been changed. Further information: Appendix II: Customer Letter Disconnect the MODULARIS manual control from the MODULARIS Variostar basic unit and reconnect it. The manual control will start automatically and display the correct values. Then treatment can continue.

Device

Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 1023423018...

Manufacturer

Siemens Ltda.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA