Alerta De Seguridad para Commercial Name: Surgical Tables. Technical Name: Surgery Table. ANVISA registration number: 80259110066. Risk class: I. Model affected: OTESUS 1160. Serial numbers affected: 28; 199

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; MAQUET GMBH.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Please make sure that all persons within your organization who use the above devices and any other person who needs to know receive this field security notification. If you have passed the product to a third party, please send a copy of this notice or tell MAQUET to get in touch for further clarification. Please keep this notice with the instructions for use of the device, at least until corrective action has been taken. 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: 03/03/2018 - Date of notification notice for Anvisa: 03/23/2018 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
    As part of the post-marketing surveillance of the company holding the registry, (3) cases were reported to maquet in which the column was not functioning due to battery malfunction. the root cause of the failure was, in all cases, the inflow of liquids, usually during cleaning or during the procedure. intake of liquids may result in a potential hazard due to smoke from the spine, hot surfaces and / or suspension of the operating table. in these three cases, only two patients were involved. while transferring the tabletop to the spine, the medical staff noticed a white smoke coming from the spine. the patient was transferred to another table top in both cases. no case of serious injury to a patient or user has been reported to maquet.
  • Acción
    Field Action Code Cover 2018-001 Unleashed under the responsibility of the Company Maquet do Brasil Equipamentos Medicos Ltda. Field Correction


  • Empresa matriz del fabricante (2017)
  • Source