Events

Alerta De Seguridad para Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registration: 10216710153 ////. Model: INTEGRISH5000 F, Record: 10216710034 ////. Model: Integris Allura 12/15, Integris Allura 12 / 15F, Integris Allura 9C, Integris Allura 9F; Record: 10216710155 ////. Model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; Record: 10216710206 .. Serial number: 176; 553; 759; 1751; 001H021796; 001H021878; S4F010159A; S4F200174A; S4F200270A

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
    1514
  • Fecha
    2015-02-05
  • 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, the risk is linked there is a possibility of collision of the equipment with the patient or with the staff present in the room. When suspended from the ceiling of the monitors, it may fall to its lowest position. There is also the possibility that the ceiling suspension of the monitors collide with other equipment that is close to it.
  • Causa
    According to the record holder, the ceiling suspending system of the equipment monitors may plummet to its lowest position which, after investigation pointed out that the cause of the failure was a montage suspended ceiling trigger assembly error.
  • Acción
    The registrant has established the following guidelines for customers until the containment action is implemented: - Do not position or move the ceiling suspension of the monitors on the patient - Do not allow team members to be under or near the suspension monitors.- Avoid any unnecessary movement of the monitors suspended ceiling. " (SEE ATTACHED)

Device

Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ...

Manufacturer

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