Events

Alerta De Seguridad para FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIRD PRODUCTS CORP SUB THERMO ELECTRON 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
    84
  • Fecha
    2001-02-02
  • 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 alarm failure risk is alert on the fans. these fans may not detect the pressure changes in accidental cases of extinguish or disconnect between the flow tubes for the child and the "sensor" interface. this occurs when the flow sensor to the child remain connected to the circuit. these fans may also fail to impose respirators when used with the sensor in tcpl simv mode, programmed for low assistance sensitivity. the manufacturer began this correction in letter of 28 september 2000.
  • Acción
    VERIFY THAT YOU HAVE RECEIVED THE IBRD CORRECTION NOTIFICATION LETTER ON SEPTEMBER 28, 2000, REGARDING THE CPUS A, BE MONITOR OF VOLUME; INSTALLATION INSTRUCTIONS AND BIRD PRODUCTS VERIFICATION SHEET. IDENTIFY AND ISOLE THESE PRODUCTS. AGENDE WITH THE IBRD TECHNICAL SERVICE TO COME TO YOUR ESTABLISHMENT TO CHANGE THE CPUSES OF EACH OF THESE FANS. THEN COMPLETE THE CHECK FORM AND RETURN IT TO THE IBRD, ADJUSTMENT DEPARTMENT, BY FAX (0021-1-760-778-7274) OR BY MAIL (TO ADDRESS: 1100 BIRD CENTER DR, PALM SPRINGS CA 92262-8099 USA ). FOR FURTHER INFORMATION CONTACT YOUR IBRD OR TELEPHONE REPRESENTATIVE (0021-1-760-778-7200)

Device

FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

Manufacturer

BIRD PRODUCTS CORP SUB THERMO ELECTRON CORP.
  • Source
    ANVSANVISA