Alerta De Seguridad para X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 31001/50215/95920/95921/95933/320113.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

¿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
    1544
  • Fecha
    2015-03-23
  • 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
    According to the registry holder, there is a serious accident for the patient and operator / technician resulting from the problem: "For the patient: • There is a possibility of disconnection or movement of invasive medical devices. For the Operator / Technician: • There is a possibility of there are compression / crush points in the substructure; and • A possibility of retention between the table and the gantry if the Operator / Technician positions between them to move the patient forward.
  • Causa
    Considering that the maintenance latch is secured and the stem of the maintenance latch is broken, the tabletop can float freely, causing an involuntary horizontal movement.
  • Acción
    The company directs the operator to notice a horizontal free floating movement of the table during normal clinical use, immediately stop using the system and contact your Maintenance Engineer. It is important to keep the Safety Warning with the Instructions for Use (IFUs) of the equipment.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA