Events

Retiro De Equipo (Recall) de Sidhil Inspiration Cot

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Midmed 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-00345-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-09
  • 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-00345-1
  • 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
    Following a period during which an active child had been left unattended in a 9003 inspiration cot the child was found by a consultancy paediatrician with his top wrapped around his head with the clothing hanging from the cots latch mechanism. the child had lifted up the tubing/cable access latch, which is located on the top rail at the head or foot end of the cot and managed to get his sleeve caught on the latch. upon trying to free himself the child managed to free his arms but was left with his clothing wrapped around his head, with the clothing still being caught on the top of the cot via the latch. the child was freed and no injuries were sustained.
  • Acción
    Midmed is replacing the cable access cot ends with standard cot ends for all cots not used in critical care/intensive care.

Device

Sidhil Inspiration Cot
  • Modelo / Serial
    Sidhil Inspiration CotProduct Code: 9003ARTG Number: 167177
  • Manufacturer
    Midmed Pty Ltd

Manufacturer

Midmed Pty Ltd