Retiro De Equipo (Recall) de Minstrel Patient Transfer Lift with Scale

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh Healthcare 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-00790-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-15
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Arjohuntleigh received a limited number of reports where the bolt under the scale unscrewed from the scale. this issue may cause the spreader bar bolt to unscrew from the scale and detach the spreader bar from the device.
  • Acción
    ArjoHuntleigh would like to provide the following options to ensure continued safety and performance of your Minstrel Lift. Option 1: The Minstrel Lift devices are close to their intended 10-year lifetime and ArjoHuntleigh would like to offer our customers a trade-in discount to purchase a new Minstrel ArjoHuntleigh patient transfer lift. Option 2: An ArjoHuntleigh Service Technician will install a new scale with added locking features, to your existing Minstrel Lift, free of charge. If Option 2 is chosen, ArjoHuntleigh want to remind you that the Minstrel lift is near its intended 10-year lifetime and it should not be used past its lifetime, including installation of the new scale.

Device

  • Modelo / Serial
    Minstrel Patient Transfer Lift with Scale Serial Numbers: MPLAT0502W1403, MPLAT0502W1404, MPLAT0504W1518, MPLAT0504W1519 ARTG number: 200785
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA