Events

Retiro De Equipo (Recall) de Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bosco Medical Australia.

¿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
    RC-2016-RN-00429-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00429-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has identified two issues relating to the power supply;- that the two halves of the power supply may come apart. if the two halves are not properly closed, there is a low risk of injury by electricity. as the conductive parts are secured by a fuse, severe injury is prevented. - the screw on domes for the housing of the power supply may break, and as a result, the housing itself may partially or completely come apart due to carious factors.It cannot be ruled out that the two issues may coincide and there is a low risk of injury by electricity.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Bosco has advised users to inspect power supply units for any defects. Any affected devices should be returned to Bosco for replacement with unaffected units. This action has been closed-out on 17/08/2016.

Device

Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)
  • Modelo / Serial
    Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)Model Number: 55-12-500Serial Numbers: 1506-CC02-0039, 1506-CC02-0040ARTG Number: 118226
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia