Events

Retiro De Equipo (Recall) de Allura Systems: Field extensions Vascular R7.6

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-00105-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-06
  • 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-2015-RN-00105-1
  • 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
    Philips has received customer feedback where the monitor ceiling suspension (mcs) system fell to its lowest position. in this specific occasion it collided with the table top. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs. when the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room or with other equipment in close proximity of the mcs.
  • Acción
    Philips will replace all MCS actuators on affected devices. Until this action can be undertaken straps being fitted around the MCS to prevent the monitors from falling down in the event that the actuator fails. In order to avoid any risk for patients, users or bystanders are recommended the following until the containment action has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 03/08/2016.

Device

Allura Systems: Field extensions Vascular R7.6

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA