Events

Retiro De Equipo (Recall) de SIM System with SIM dock power supply model Franmar FRA012-S05-I

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Simavita Aust 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-00076-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-03
  • 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-00076-1
  • 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
    Simavita has recently received notification from their third party supplier that the plug adaptor, which is provided together with the sim dock power supply, has a design fault. under some circumstances, one of the pins from the plug adaptor may detach during removal from the power point and remain protruding from the power point creating an electrocution hazard.
  • Acción
    Customers are advised to:- 1. Identify the location of the SIM dock power supplies at their facility; 2. DO NOT unplug any of these power supplies that are currently plugged into a power point. The risk of electrocution only occurs where the pin has become detached from the plug adaptor & remains in the power point. 3. Immediately notify internal maintenance personnel in order to carry out safe removal of the power supplies from each outlet. Following safe removal all units must be quarantined until the product correction has been carried out; 4. Where one of these power supplies is not currently plugged into a power point, DO NOT plug in & use that power supply & quarantine the units as per internal procedures; 5.Immediately inspect any power points for the above fault in locations where it is known this device is regularly used & notify appropriate internal personnel in the event this anomaly is identified; and 6. Share this Notification internally to all appropriate staff. This action has been closed-out on 18/07/2016.

Device

SIM System with SIM dock power supply model Franmar FRA012-S05-I
  • Modelo / Serial
    SIM System with SIM dock power supply model Franmar FRA012-S05-I ARTG Number: 227029
  • Manufacturer
    Simavita Aust Pty Ltd

Manufacturer

Simavita Aust Pty Ltd