Events

Retiro De Equipo (Recall) de Bard Arctic Sun Temperature Management System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medivance Inc.

¿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
    17158
  • Fecha de inicio del evento
    2014-08-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Causa
    Two adverse events have been reported to the manufacturer. in each instance, a temperature simulator key was connected to the patient temperature cable instead of the patient temperature probe. due to the false patient temperature reading from the temperature simulator key, improper targeted temperature therapy was delivered to the patients by the arctic sun® 5000.
  • Acción
    Manufacturer to issue advice regarding use

Device

Bard Arctic Sun Temperature Management System
  • Modelo / Serial
    Model: Catalogue Numbers: 5000-01, 748-00, 771-00, Affected: All lots
  • Manufacturer
    Medivance Inc

Manufacturer

Medivance Inc