Alerta De Seguridad para Trade name: Patient lift. Technical Name: Patient Lift. ANVISA registration number: 80259110103. Class of risk: - Low Risk. Model Affected: Maximove. Serial numbers affected: 300044700; 300070780-300070791; 300050411; 300050413; 300072093; 300072094.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA.; ArjoHuntleigh AB.

¿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
    2054
  • Fecha
    2016-10-03
  • 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
    As part of efforts to ensure customer satisfaction and product quality and performance, ArjoHuntleigh has decided to replace manual control for the Maxi Move floor lifts affected by this problem. This is not expected to affect the safety of the device, but its durability. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link . #### UPDATED ON 09/4/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    Premature wear of manual control. internal tests and research activities that conductive ink, which is necessary for activation of manual control function, did not meet the predetermined durability requirements.
  • Acción
    Field Action Code TAN 07-2016 triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA. Company will make field correction as directed in the Letter to customers.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA