Events

Alerta De Seguridad para (1) LTV 900, (2) LTV 950, (3) LTV 1000, SERIAL NO. (1) LESS THAN B01541, (2) LESS THAN C01275 , (3) MINOR THAN A02066.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PULMONETIC SYSTEMS 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
    54
  • Fecha
    2001-05-14
  • 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 alarm failure risk is alert on the fans. in the cpap mode, if the patient accidentally disconnects and if the volume minute is set with parameter <0.7l / min, the alarm of these fans may not sound. beyond this, as these fans perceive self-recycled breathing as patient effort, the apnea alarm does not soar. the manufacturer began this correction in letter of april 4, 2000.
  • Acción
    VERIFY THAT YOU HAVE RECEIVED THE PULMONETIC CORRECTION NOTIFICATION LETTER OF APRIL 4, 2000. IDENTIFY, ISOLE ALL THESE PRODUCTS THAT MAY BE AFFECTED. FOR FURTHER INFORMATION CONTACT YOUR PULMONETIC SYSTEMS REPRESENTATIVE OR CONTACT JOE CIPOLLONE ON THE PHONE (0021-1-909-783-2280).

Device

(1) LTV 900, (2) LTV 950, (3) LTV 1000, SERIAL NO. (1) LESS THAN B01541, (2) LESS THAN C01275 , (...

Manufacturer

PULMONETIC SYSTEMS INC
  • Source
    ANVSANVISA