Events

Retiro De Equipo (Recall) de Monitor AC2000 Spring Arm

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

¿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-2014-RN-00406-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00406-1
  • 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
    Draeger medical australia has been informed of three cases where a welded seam in the spring-loaded arm of the monitor holder broke resulting in the monitor falling. although no injury has been reported, the risk of injury to persons positioned beneath the monitor cannot be excluded.
  • Acción
    A Drager service representative will inspect all potentially affected spring-loaded arms. A replacement arm will be provided for all devices determined to be affected.

Device

Monitor AC2000 Spring Arm
  • Modelo / Serial
    Monitor AC2000 Spring ArmPart Numbers: G19051 and G19262All serial numbers affectedPart Number: G93358All serial numbers until 0111 066 23639 affectedPart Number: G93359All serial numbers until 0111 056 21343 affectedARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd