Events

Retiro De Equipo (Recall) de Ceiling mounted rail systems for Liko Overhead 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 Hill-Rom 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-2013-RN-01330-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-16
  • 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-2013-RN-01330-1
  • 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 issue relates to fasteners securing overhead lift rail systems to ceilings in chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the stainless steel hardware may occur in the presence of chlorinated environments such as swimming pool areas. there is a risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders.
  • Acción
    Hill-Rom is advising users that an inspection will be carried out on all potentially affected systems located in a chlorinated environment and if systems are found to be of stainless steel hardware, it will be replaced with unaffected hardware. Hill-Rom is reminding users that periodic inspections are required for the rail systems in accordance with the Instructions for Use (IFU). For more details, please see http://www.tga.gov.au/safety/alerts-device-liko-overhead-lifts-140121.htm . This action has been closed-out on 11/02/2016.

Device

Ceiling mounted rail systems for Liko Overhead Lifts

Manufacturer

Hill-Rom Pty Ltd