Events

Retiro De Equipo (Recall) de StimPod NMS 450 Nerve Stimulator

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 Xavant Technology.

¿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
    16612
  • Fecha de inicio del evento
    2014-05-02
  • 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: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • Causa
    In isolated incidences (less than 0.003%) 0 while using the device in nmba monitoring mode, electrodes used may deteriorate to a level where current densities may be large enough to cause superficial burns on the skin of the patient. the occurrence of this phenomena is due to a lack of training on the impedance monitoring fucntion of the device and it is imperative that users are properly trained to monitor the impedance of the electrode/skin impedance through the actual current delivered function in mnba with all stmpof nms450s.
  • Acción
    Instructions for use to be updated

Device

StimPod NMS 450 Nerve Stimulator
  • Modelo / Serial
    Model: XT-45011, XT-45011-NA, XT-45001 and XT-45001-NA, Affected:
  • Manufacturer
    Xavant Technology

Manufacturer

Xavant Technology