Alerta De Seguridad para Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Name: Anesthesia System Carestation. Technical Name: Pulmonary Ventilator. ANVISA registration number: 80071260334. Class of risk: III. Affected Model: Carescape R860. Serial numbers affected: See attached list

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; Datex-Ohmeda 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
  • 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
    You can continue to use the system. If EC01 or EC09 fails, restarting the system may restore proper functionality. System performance is not affected on devices where such display failure does not occur. However, to make changes to the fan settings depends on the data normally available in the fan display, and therefore, the patient needs to be changed to another fan. In case this problem occurs, an audible alarm will sound. Mechanical ventilation will continue in the previous settings. Device restart is required to disable the alarm condition. Consider using appropriate alternate ventilation means, such as a self inflating bag or other fan to avoid injury to the patient when restarting the device. 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: 07/13/2017 - Date of notification notice to Anvisa: 09/02/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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
    There is a possibility that the image processor may fail unexpectedly. if this fault occurs, the device screen will be temporarily blank and will display error code "ec01 xx". the blank display results in the loss of monitored data being displayed to the user.
  • Acción
    Field Action Code IMF 34087 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Will make correction in the field.