Events

Retiro De Equipo (Recall) de ESOPHAGEAL COOLING DEVICE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ATTUNE MEDICAL.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    142098
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-08-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    One lot of catalog # ecd02-b medical devices distributed in canada (lot # 199136216a) may contain a significant percentage of devices with an excessive amount of adhesive in one of the bonded joints. the excessive adhesive may significantly restrict or prevent fluid flow through the device. this issue can be immediately recognized by the end user as the external console has a low flow alarm that will indicate to the user that fluid is not properly flowing through the device upon connection of the device and initiation of fluid flow.

Device

ESOPHAGEAL COOLING DEVICE
  • Modelo / Serial
    Model Catalog: ECD02-B (Lot serial: 199136216A)
  • Descripción del producto
    ESOPHAGEAL COOLING DEVICE / ENSOETM
  • Manufacturer
    ATTUNE MEDICAL

Manufacturer

ATTUNE MEDICAL
  • Dirección del fabricante
    CHICAGO
  • Source
    HC