Events

Alerta De Seguridad para Magnetic Resonance Equipment, record 80005260011. Serial Number Y012

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HITACHI SISTEMAS MÉDICOS DO BRASIL LTDA.; Hitachi Medical Corporation.

¿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
    1432
  • Fecha
    2014-10-02
  • 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 manifestation of the company, the root cause of this failure has already been determined. The company believes that the risk of injury is low but, as a precaution, decided to change the materials used in the Gradiente Coil to reduce the risk of recurrence and to mitigate any risk of damage. Corrective action will be applied to systems installed before 1 August. The company also reports that only one equipment was installed in Brazil.
  • Causa
    One of the gradient coils on the installed base of the echelon oval suffered a flaw that resulted in a small amount of smoke in the magnet room and a sound accompanying the event. there were no injuries as the system is designed to provide adequate protection and contain these types of system failures. in this particular case, the fault occurred under the back of the patient's "tunnel". this problem has been identified in the united states.
  • Acción
    The company that holds the registration in Brazil informs that there are no restrictions on the use of the system until field correction occurs.

Device

Magnetic Resonance Equipment, record 80005260011. Serial Number Y012

Manufacturer

HITACHI SISTEMAS MÉDICOS DO BRASIL LTDA.; Hitachi Medical Corporation
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    ANVSANVISA