Events

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: 58524531; 5,877,142; 61676906; 61701347; 61877637; 61965826; 6,213,815; 62218321; 62829796; 6,308,7087; 63090577; 6,374,4537; 63820666; 63842205; 63912144; 63929459; 64046882; 64075140; 62506739.

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
    1508
  • Fecha
    2015-02-11
  • 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, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
  • Causa
    According to the registry holder there is a possible vertical brake failure, which may lead to uncontrolled movement of the patient's bed. there are no reports of users being injured.
  • Acción
    The record holder's recommendations, in the event of an uncontrolled vertical movement of the patient's bed, the use of the equipment should be discontinued and the user should contact the local care provider. The company does not guide stopping in the use of the bed. Users who prepare and operate the system with the patient should be aware while the patient is on or near the Patient Bed, especially in the case of intubated patients or in similar situations. These guidelines must be followed until the equipment is corrected.

Device

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Reg...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA