Alerta De Seguridad para Trademark: Vital Signs Monitor SureSigns VS. Technical Name: Vital Signs Monitor. ANVISA registration number: 10216710328. Risk class: III. Affected Model: SureSigns VSi; SureSigns VS2 +. Serial numbers affected: Model: SureSigns VSi; Serial Numbers: CN42728255 and CN42728256; Model: SureSigns VS2 +; Serial Numbers: CN42728253 and CN42728254

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.

¿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
    2424
  • Fecha
    2017-10-18
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    Affected products may continue to be used because this Date of Manufacture information on the serial number label has no impact on any function or operation of 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: 18/09/2017 - Date of notification notice for Anvisa: 12/18/2017 The company holding the record of 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
    Some suresigns vsi and vs2 + products have the date of manufacture on their serial number label as "% dom" instead of the specific date in the yyyy-mm format.
  • Acción
    Field Action Code FCO86000241 triggered under the responsibility of the company Philips Medical Systems Ltda. Philips will provide a new "Date of Manufacture" label for each affected unit. An instruction will be provided to the affected client on how to perform the fix. Philips Healthcare will contact you to arrange the correction.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA