Alerta De Seguridad para Trade name: Steam Sterilizers GSS67H. Technical Name: Autoclave. ANVISA registration number: 80259110131. Hazard class: II. Model Affected: Steam Sterilizers GSS67. Serial numbers affected: 0011218904-010-01; 0011218904-060-01

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; Getinge Sterilization 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
    2429
  • Fecha
    2017-11-07
  • 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
    The equipment has not yet been marketed and, therefore, there are no recommendations to users and patients. 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 Additional information: - Date of identification of the problem by the company: 06/19/2017 - Date of notification notice for Anvisa: 07/12/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Getinge sterilization ab updated the design of the gss67 * series by replacing the abb ast35 electrical power connection points with 35mm2 spring-type terminals. the reason is production feedback that it is difficult to connect the cables with the right torque and customer complaints. some cases had merge / missing connection points and this was caused if the electrical installation on the site was not done correctly. only steam generator sterilizers were seen as having a problem due to the high energy consumption. this change must be made to minimize further incidents in our customers and to make the service and installation less fragile.
  • Acción
    Field Action Code GSS 67 - Power Connectors triggered under the responsibility of Maquet Do Brasil Equipamentos Medicos Ltda. Will make field correction

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA