Events

Retiro De Equipo (Recall) de Entroy Pool Lifter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Arjo 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-2018-RN-00230-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-26
  • 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-2018-RN-00230-1
  • 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
    Arjo have identified a potential for the chair or stretcher detachment from entroy pool lifter. it is identified that this issue is caused by a potential misalignment that might be unnoticed by the caregiver so the seat/stretcher does not get fully paired with the pin. instead, once the lift reaches certain height, the seat/stretcher falls off the lift. there are one or more possible reasons that can lead to such a situation to occur: - maintenance checks not performed properly,- users do not recognize the poor connection,- pool lift owners does not recognise that the product needs maintenance, - wear on the docking connection causes the pin to hit the edge of the pairing cylinder instead of entering it.
  • Acción
    Arjo are advising users that they will arrange for an on-site service technician visit to install a Quick Reference Guide, which is an illustration-based instruction, which users may refer to ensure a patient transfer is conducted as indicated in the IFU.

Device

Entroy Pool Lifter
  • Modelo / Serial
    Entroy Pool LifterModel Number: GAB1000-x01Affected Serial Numbers 810000957 up to T3387 ARTG: 230595Arjo Australia - Lift, patient transfer, stationary
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA