Events

Retiro De Equipo (Recall) de Fisher & Paykel Bubble CPAP Starter Kits

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 Fisher & Paykel Healthcare SA de CV.

¿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
    16543
  • Fecha de inicio del evento
    2014-04-16
  • 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: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Causa
    Manufacturer has received customer reports relating to certain lot numbers of certain models of the nasal cpap prongs detaching from the fph flexitrunk nasal tubing., fph introducred a new version of nasal cpap prongs in 2013 and the lot numbers and models incorporate this new version. since the release of this new version fph has received reports of the affected prongs detaching from the nasal tubing during use especially in the presence of mucous and/ or moisture.
  • Acción
    Product to be destroyed

Device

Fisher & Paykel Bubble CPAP Starter Kits

Manufacturer

Fisher & Paykel Healthcare SA de CV