Events

Alerta De Seguridad para Physiological monitoring systems, by telemetry. 18-inch flat-panel, touch-screen color LCD monitor for PatientNet, Visa and Visa II Central Stations. Part No. 0160-00-0059; Serial numbers: 01-9682, 01-9683, 01-9685, 01-9686, 01-9688, 01-9690, 01-9694, 01-9695, 01-9696, 01-9698, 01-9699, 01- 9700, 01-9703, 01-9704, 01-9901

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Datascope Corp Patient Monitoring Div.

¿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
    325
  • Fecha
    2001-11-02
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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 THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above monitors may drop when a user attempts to tilt the top of the monitor to an angle that exceeds 5o forward or 45o backward relative to its vertical position. the monitor is not secure at the base. there is no associated risk to the patient, as long as the monitor is not installed in the vicinity of the patient; however, a greater risk of physical injury to the patient or to the user may exist when the monitor is maneuvered because it is in an unstable position, which can cause the monitor to drop. the manufacturer initiated the correction by letter dated june 28, 2001.
  • Acción
    Please verify receipt of a letter dated June 28, 2001 from Datascope. Identify and isolate all affected products in your inventory. Your local Datascope representative will upgrade your monitor by adding a stabilization plate to its base that will prevent the unit from overturning. In addition, your operator's manual will be updated to alert the user to use a device at the base of the monitor if it is intended to tilt the monitor head more than 45o to prevent it from falling backwards. This work will be free. For more information, contact your local representative or directly with Datascope at 1 (201) 995-8237 in the United States.

Device

Physiological monitoring systems, by telemetry. 18-inch flat-panel, touch-screen color LCD monito...

Manufacturer

Datascope Corp Patient Monitoring Div
  • Source
    ANVSANVISA