Alerta De Seguridad para Trade name: GE T2100 Ergometer Treadmill. Technical Name: Treadmill. ANVISA Registration Number: 80071260189. Hazard Class: I. Affected Model: GE T2100 Ergometer Treadmill. Batch / Affected Series Numbers: GE T2100 Ergometer Treadmill

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; GE Healthcare Critikon de Mexico S de RL de CV.

¿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
    For the recommendations given by the company, access the letter to the customer available at: LINK: -file-ergometer-ge-t2100-installation-of-parts-reserve-may-result-in-motion-off-the-tape-d / 33868? p_p_auth = bSxZsrle & inheritRedirect; = false & redirect; = http% 3A% 2F% 2Fportal If you want to notify technical and technical complaints, please contact us at the following link: adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Vigilance 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 notification notice to Anvisa: 04/18/2018 The company holding the record of the affected product is responsible for contacting its clients in a timely manner to ensure the effectiveness of the ongoing Field Action. 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
    The t2100 treadmill performance problem with customer proprietary spare parts (2026182-002 or 2026182-004) was not solved with the previous safety fix (gehc fmi 30074). if these parts were installed from the customer's reserve stock on the t2100 treadmill, uncontrolled movement of the locomotive strap may occur during the exercise test exercise. this movement may be seen as an unexpected slowdown, followed by a sudden acceleration of the belt in forward or backward direction. when this occurs, even when the stop button is pressed, the movement of the strap does not stop immediately. instead, it will stop in up to 35 seconds by slowing down the maximum speed. sudden change in speed and / or belt direction can result in falls and injuries to the patient.
  • Acción
    Field Action Code IMF 30085 triggered under the responsibility of the company GE Healthcare do Brasil, Com. for Equipos Médico-Hospitalares Ltda. Field correction.