Events

Alerta De Seguridad para COMPONENTS FOR ANESTHESIA WITH SOFTWARE VERSION C.0, OF THE PHYSIOLOGICAL MONITORING SYSTEMS MODELS NOS. (1) M1165A, (2) M1166A, (3) M1167A, (4) M1175A, (5) M1176A, (6) M1177A, EEPROM NOS .: (1 À6) M1059-81242, M1059-81262

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP.

¿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
    37
  • Fecha
    2001-03-14
  • 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 monitor may erase and resume if the record button on the remote control is tighten in a sustained way, or if an alarm releases, causing transition failure of the functions.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWAL IN NOVEMBER / 2000. IDENTIFY AND INSULATE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. EEPROM NUMBERS CAN BE FOUND IN THE SYSTEM COMPONENT IF YOU DO THE FOLLOWING STEPS: (1) PRESS THE INSTRUMENT SETUP OR MONITOR SETUP BUTTON. (2) PRESS THE MORE CHOICES BUTTON IF AVAILABLE. (3) PRESS THE MONITOR REVIEW BUTTON. THE MONITOR REVIEW CIRCLE APPEARS WITH THE EEPROM NUMBER IN THE CENTER OF CAIXA DE CIMA. TO REQUIRE THE ENGINEER TO VISIT WHICH WILL INSTALL FREE TRANSFER VERSION FREE OF CHARGE, CONTACT AGILENT TECHNOLOGIES RESPONSE CENTER BY PHONE 00XX 1 (877) 811-1710 OR (987) 687-1501.

Device

COMPONENTS FOR ANESTHESIA WITH SOFTWARE VERSION C.0, OF THE PHYSIOLOGICAL MONITORING SYSTEMS MODE...

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA