Events

Retiro De Equipo (Recall) de InTouch Critical Care Bed

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-2014-RN-00727-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-04
  • 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-2014-RN-00727-1
  • 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
    Stryker has received complaints from the field regarding intouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. these broken casters are identified when the intouch beds are hoisted or lifted from the floor during regular maintenance. if more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged, brake functionality continues to meet specifications.
  • Acción
    A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion.

Device

InTouch Critical Care Bed
  • Modelo / Serial
    InTouch Critical Care Bed Item Number: 2156000000 All lots affectedARTG Number: 202755 (cancelled 21 March 2014)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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