Alerta De Seguridad para Ultrasound System Technical Name: Ultrasound Device ANVISA Registration Number: 80071260360 Hazard Class: II Affected Model: Vivid S60, Vivid S70 Affected Batch / Series Numbers: Vivid S60 / Vivid S70 with Software Version 201, Revision 55.0 and 63.0

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 MEDICAL SYSTEMS, ISRAEL LTD. / GE MEDICAL SYSTEMS (CHINA) CO., LTD.

¿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
    The following actions are recommended: 1. After selecting a patient in the DICOM worklist, be sure to review and confirm that patient demographics shown on the ultrasound scanner screen during the examination are of the intended patient. 2. In scenarios where the incorrect and / or actual patient already exists in the patient file, a 'Patient Match' dialog box will be displayed to inform you of inconsistent patient information. Be sure to properly analyze patient demographics. 3. To reduce the likelihood of a problem occurring, reduce the DICOM worklist search size by: a) Setting 'maximum results' to 75 in the Worklist Data Flow Setup dialog box (available when you select Configuration | DICOM Worklist * Properties) and / or b) * Configuring the DICOM worklist server to automatically delete 'scheduled procedure steps' that were performed on the ultrasonic scanner . If this option is not available on your DICOM worklist server, be sure to manually clear all scheduled 'procedural steps' that were run on the DICOM worklist on a regular basis (for example, every day).
  • Causa
    Ge healthcare has become aware of a problem where a patient other than the intended patient is incorrectly selected by the operator in situations where the response time of the dicom worklist search is slow. this problem is limited to certain vivid ultrasound systems and may result in incorrect patient information shown on the screen during the examination.
  • Acción
    Field Action Code IMF 76168 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.