Events

Retiro De Equipo (Recall) de Oscor Electrode Cable

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 Oscor 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
    21516
  • Fecha de inicio del evento
    2017-06-09
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    In some cases during the use of some atar™ reusable extension cables, the cables was separating from the connector at the proximal end. the analysis of the returned devices revealed that the connector and wire separation was attributed to a fracture of the conductor cable most likely caused by extensive use of the reusable cables beyond the recommended maximum amount of 3 times. this event resulted in cable malfunction, causing interruption of the pacing system.
  • Acción
    Product to be returned to supplier

Device

Oscor Electrode Cable

Manufacturer

Oscor Inc
  • Empresa matriz del fabricante (2017)
    Oscor Inc.
  • Source
    NZMMDSA