Events

Retiro De Equipo (Recall) de Carina Mobile LiftsAll Models and Series

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Active Medical Supplies 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-2017-RN-00516-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-12
  • 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-2017-RN-00516-1
  • 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, handicare, has identified the possibility that the carina mobile lift could be mounted incorrectly by users in two respects. namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.E. piston rod eye flange) fractures when subjected to certain weight loads. in the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use.
  • Acción
    Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's website.

Device

Carina Mobile LiftsAll Models and Series

Manufacturer

Active Medical Supplies Pty Ltd