Events

Alerta De Seguridad para Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling), FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20. Risk class: III, Record: 10216710153 and 10216710206.

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 Nederland B.V..

¿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
    1623
  • Fecha
    2015-07-02
  • 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 record holder's information, there is a possibility of collision of the equipment with the patient or with the staff present in the room when the ceiling suspension of the monitors falls to their lowest position. There is also the possibility that the ceiling suspension of the monitors will collide with other equipment that is close to it. #### UPDATED ON 7/18/2017, the company sent a field action completion report confirming the replacement of the part , as provided.
  • Causa
    According to the record holder, a fault in the allura xper system monitor ceiling suspension (mcs) was found.
  • Acción
    The company that owns the registry will make a correction in the equipment field. A containment action will be taken in which loops will be attached to the MCS to prevent them from falling. It is recommended that the user does not position or move the monitor ceiling suspension above the patient and do not allow the staff to be below or near the ceiling suspension of the monitor.

Device

Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling),...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA