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. Serial numbers affected: 4263; 4798; 5198; 5205; 5321; 5379; 5476; 5880; 5880; 5923; 6412

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Anima Médica Comércio Importação e Exportação Ltda; Esaote S.p.A..

¿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
    Until Customer receives and has installed corrective software update, o Until Customer receives corrective software update, user must refrain from using ElaXto (Elastomonography Application) mode in the following clinical applications where the patient is unconscious or sedated: Intraoperative and Neurosurgery. The user is also asked to check the surface temperature of the probe head in ElaXto mode prior to use in all other applications. In the event that the user experiences an overheating as described above, they are required to refrain from using the system in ElaXto mode. 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: 19/01/2018 - Date of notification notice to Anvisa: 12/28/2017 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
    Esaote recently learned of a potential security issue as described below. original probe settings in elaxto mode (application in elastomonography) may not be suitable for certain probes, as listed below, which may result in overheating of the probe contact surface: bl433; c 1-8; ca541 ec1123; ec123; ih 6-18; iot332; iot342; l 4-15; la332e; la435; la523; la533; si2c41; sl2325 and trt33. to date, no patient injury has been reported in relation to this potential problem. with the original elaxto mode settings, the contact surface of the probe can overheat in about 1 (one) minute. the patient may experience discomfort, redness of the epidermis and / or mild pain. we note that the reported problem is in software versions 12.10 to 13.60 in elaxto mode (elastomonography) that can be used with the equipment listed.
  • Acción
    Field Action Code 20000995 triggered under the responsibility of the company Anima Médica Comércio Importação e Exportação Ltda. Will make field correction