Events

Retiro De Equipo (Recall) de Prism Medical P300 and C300 Lifts

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Rehab Assist 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-2015-RN-00967-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-30
  • 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-2015-RN-00967-1
  • 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
    Prism has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents we have discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur atthe same time there is a risk for the person being supported by the lift to drop unexpectedly. the patients involved in the 3 incidents were not seriously injured and did not require medical attention.
  • Acción
    Rehab Assist will replacing the affected units with a new unit. For further information please see https://www.tga.gov.au/alert/prism-medical-p300-and-c300-ceiling-hoist. This action has been closed-out on 18/08/2016.

Device

Prism Medical P300 and C300 Lifts
  • Modelo / Serial
    Prism Medical P300 and C300 LiftsLifter P300Models: 303050; 303051Serial: P303470 – 479, P304158/164/171/172, P304536 – 539, P304866/867, P305116/118, P305125 – 127, P305130/134/135Lifter C300Models: 330050; 330053Serial: C303221/224/225, CQ303107 – 116Lifts manufactured prior to 8 June 2015ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd