Events

Retiro De Equipo (Recall) de Invacare Birdie Lifters (Patient lifters)Lifter Birdie (180KG-EL-JC)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare 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-2016-RN-01287-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-06
  • 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-2016-RN-01287-1
  • 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
    Invacare are updating the instructions for use with respect to correct assembly of the d-clip that connects the actuator to the birdie lifter’s arm. as a result of some reports overseas where the actuator’s d-clip becomes damaged and the lifter arm falls down, invacare have become aware that if the d-clip is always placed backwards and pointing down towards the actuator (incorrect assembly), it can start to become damaged after a number of cycles. if the d-clip becomes damaged to the extent that the lifter arm falls down then there is potential for a serious patient injury to occur. when the clip is in the wrong position the bending (damage) of d-clip only happens if it is touching the actuator backwards and at its maximum height. the clip will also bend severely when over 140kg is used with the device. the complete clevis pin (quick release pin) doesn’t detach immediately from the actuator when the d-clip becomes damaged - the pin stays in the arm’s plates that hold the actuator.
  • Acción
    Invacare is advising customers that the following should be checked on each Birdie Lifter. 1. The actual state of the D-clip - does it appear bent or broken? If the D-clip is damaged or broken, Invacare should be contacted and they will provide replacement stock. 2. The actual position of the D-clip in the lifter. If it is in the correct position, there is no need to change it. If it is assembled in the wrong position, the D-clip should be removed and reassembled according to the directions that are being provided. Revised instructions for use are avaliable.

Device

Invacare Birdie Lifters (Patient lifters)Lifter Birdie (180KG-EL-JC)
  • Modelo / Serial
    Invacare Birdie Lifters (Patient lifters)Lifter Birdie (180KG-EL-JC)Item Number: 3000503.E3B00-0125Lifter Birdie (170KG EL)Item Number: 3000502.E3B00-0125Lifter Birdie CMPT (150-ML-JC)Item Number: 3000513.D3B02-0125Lifter Birdie Compact (150KG ML)Item Number: 3000512.D3B02-0125Lifter Birdie MAN (170KG-ML-JC)Item Number: 3000503D3B02-0125ARTG Number: 166395
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd