Events

Alerta De Seguridad para AGILENT INFORMATION CENTER (BEFORE HEWLETT PACKARD VIRIDIA INFORMATION CENTER) MONITORING SYSTEMS

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
    34
  • Fecha
    2001-04-14
  • 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
    Reported case of sound alarm failure in the central above, the patient was connected to a telemetry transmitter. in inspection, it was found that the outlet that connects the two independent alarm speakers with the central processing unit.
  • Acción
    THE MANUFACTURER AFFIRMS THAT THE INSTALLATION MANUAL ALERT THAT THE SPEAKER WIRE WILL NOT BE DISCONNECTED BY ACCIDENT. ECRI RECOMMENDS THE FOLLOWING: (1) ALERT THE USERS OF THESE CENTERS AND ALL PERSONAL RELEVANT TO THE PROBLEM CITED. (2) MAKE SURE THAT THE SPEAKER OUTLET IS CONNECTED PROPERLY TO THE UNIT. (3) CONTACT YOUR AGILENT TECHNICAL REPRESENTATIVE TO HAVE A SUPPORT SOCKET INSTALLED. HOWEVER, TO AVOID ACCIDENTAL FRICTION, ATTACH WITH A WIRE OR WITH A NECKLACE OF ELECTRICAL CABLES WITH SCREWS.

Device

AGILENT INFORMATION CENTER (BEFORE HEWLETT PACKARD VIRIDIA INFORMATION CENTER) MONITORING SYSTEMS

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA