Events

Alerta De Seguridad para INTERFACE WITH THE PATIENTS OF THE NIM2 AND NIM2XL MODELS OF THE NERVE ELECTROMYOGRAPHS / LOCATOR / STIMULATORS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC/ XOMED SURGICAL PRODUCTS INC. DIVISION OF MEDTRONICS 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
    12
  • 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 interface may not detect the existence of the nerve, resulting in irreversible damage during operation.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWAL ON JULY 31, 2000. HOSPITALS, CLINICS AND RELATED SURGEONS MUST CHECK THAT THEY RECEIVED MEDTRONICS NOTIFICATION. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE AFFECTED INTERFACE UNITS CAN BE DIFFERENTIATED FROM THE STANDARD MODELS BY THE MISSING DECALCOMANY SEAL AROUND THE CABLE NEXT TO THE CONNECTION TO THE MONITOR. FOR FURTHER INFORMATION, CALL MEDTRONIC XOMED, ​​00XX1 (904) 296-9600.

Device

INTERFACE WITH THE PATIENTS OF THE NIM2 AND NIM2XL MODELS OF THE NERVE ELECTROMYOGRAPHS / LOCATOR...

Manufacturer

MEDTRONIC/ XOMED SURGICAL PRODUCTS INC. DIVISION OF MEDTRONICS INC.
  • Source
    ANVSANVISA