Events

Retiro De Equipo (Recall) de Power-LOAD (Cot Fastener)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2018-RN-00296-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-09
  • 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-2018-RN-00296-1
  • 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
    After installation of the power-load, the floor plate attachment brackets (pn: 6390-101-108) which allow the power-load anchor to be secured to the power-load floor plate may be found to be broken after removing the anchor. the manufacturer has advised that broken floor plate attachment brackets will not result in unintended movement of the cot under normal conditions. the holding strength of the cot is reduced as a result of this issue which may result in a detached cot with fastener or a detached fastener component in the event of an emergency service vehicle accident. to date, there have been no reported injuries as a result of this issue.
  • Acción
    Stryker is advising that they will be replacing potentially affected parts on all Power-LOAD units manufactured within the suspected time frame. A Stryker Technician will contact users upon receipt of the Notification Response Form provided with the Customer Letter (issued to affected users) to co-ordinate the correction.

Device

Power-LOAD (Cot Fastener)
  • Modelo / Serial
    Power-LOAD (Cot Fastener)Item Numbers: 6390000000, 6390BASIC, 6390SSPAUnits manufactured between Jan 1 2016 to Dec 31 2016All serial numbers beginning with “16” are within scope of this action ARTG Number: 275902
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA