Events

Alerta De Seguridad para AIRCAST COMPRESSION UNITS OF THE VENAFLOW SYSTEM

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

¿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
    95
  • Fecha
    2001-06-30
  • 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
    Ecri reports that during the inspection of 125 venaflow systems compression units, 15 units presented ground resistance exceeding the limited limited 0.5 by the standards of the national fire protection association in health establishments, the us national fire protection associations standard for health care facilities (nfpa 99). ecri realized that various of the 15 replacement units also presented the same ground resistance problem. the manufacturer has developed a correction to the problem and adjusted all units that presented this failure, without any cost. ecri reports that revised units present ground resistance of <0.2.
  • Acción
    ACTION REQUIRED: (NOTE: PLEASE READ THE ORIGINAL REPORT BELOW TO UNDERSTAND THE REASON BEYOND THE FOLLOWING RECOMMENDATIONS.) ECRI RECOMMENDS THAT HOSPITALS CONTINUE TO MONITOR GROUND RESISTANCE MEASUREMENTS FOR COMPRESSION UNITS OF VENAFLOW SYSTEMS OF AND RETURN ANY UNIT FOR THE COMPANY FOR A FREE REVIEW AND CORRECTION, IF THE GROUND RESISTANCE EXCEEDS 0.5 OR INCREASES PROSPELY OVER TIME. FOR FURTHER INFORMATION, PLEASE CONTACT KEN OLBRISH, ECRI, BY PHONE (610) 825-6000, RAMAL 5527.

Device

AIRCAST COMPRESSION UNITS OF THE VENAFLOW SYSTEM

Manufacturer

AIRCAST INC
  • Source
    ANVSANVISA