Events

Alerta De Seguridad para Vital Matrix Monitors Press Mate Advantage: (1) Model 9861, (2) Model 9871. Serial numbers. 310004 to 311135

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

¿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
    315
  • Fecha
    2001-10-26
  • 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 vital signs monitors above may exhibit erroneous breathing level and cause false alarm or non-functioning of the alarm. the manufacturer initiated the correction by letter dated april 3, 2001.
  • Acción
    Check receipt of the letter dated April 3, 2001 from Colin Medical Instruments. Identify the isolate all affected products in your inventory. The company claims that approximately 80% of this correction was complete on October 16, 2001. This correction should be finalized on November 30, 2001. For more information, contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257

Device

Vital Matrix Monitors Press Mate Advantage: (1) Model 9861, (2) Model 9871. Serial numbers. 31000...

Manufacturer

Colin Medical Instruments Corp
  • Source
    ANVSANVISA