Alerta De Seguridad para TREATMENT TABLE FOR LINEAR PRIMUS / ONCOR / ARTISTE ACCELERATOR. Registers in Anvisa # 10234230073 (PRIMUS), 10234230125 (ONCOR) and 10234230172 (ARTISTE).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Medical Solutions; 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
    1142
  • Fecha
    2012-06-18
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Information submitted by Siemens Ltda: Siemens received reports where a drop of the treatment table was observed while the table was moving during operation by manual control. These incidents have been identified due to an internal software timing problem that occurs sporadically. Typically, the desktop software initiates engine control initialization only when the table is stationary. In certain situations the vertical motor control is initialized during table movement. In this particular case, the short time - until the brake has full effect - can lead to a drop down the table for a short distance. On the basis of reports received by the manufacturer from abroad, and after analysis of the problem, the manufacturer carried out the analysis of all the inherent risks and in order to avoid the occurrence of such failure and to improve the inherent safety of the system, a new version of the VD00A software to the patient table. In this way, the Siemens Service representative will perform in the field the modification of the affected systems in order to correct the detected problem. Siemens will perform an upgrade to correct the potential safety problem with the linear accelerator treatment table. A new VD00A version of the treatment table software will be installed. Using the affected systems, if it does present the problem, can cause the table brake to slow down and slide down a little before the brake takes effect and may frighten the patient.
  • Causa
    Fall of the treatment table was observed while the table was moving during operation by means of manual control.
  • Acción
    Siemens has already begun sending mail to affected customers and will fix the equipment (software update) in the next few days. If you have the equipment at your health care facility, keep the problem letter (sent by Siemens) along with the owner's manual and wait for the software update from the desk. Please pass the information on this alert to all users of the product.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA