Events

Retiro De Equipo (Recall) de FPH IW900-series Infant Radiant Warmers

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 and Paykel Healthcare 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
    17640
  • Fecha de inicio del evento
    2014-11-06
  • 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
    The manufacturer is recalling selected infant warmers because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however, there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
  • Acción
    Product to be modified

Device

FPH IW900-series Infant Radiant Warmers
  • Modelo / Serial
    Model: Model Numbers: IW910xxx, IW920xxx, IW931xxx, IW932xxx, IW933xxx, IW934xxx, IW951xxx, IW952xxx, IW953xxx, IW954xxx, IW980xxx, IW990xxx, Affected: Date of manufacture: 16- Nov-2007 to 10-Aug-2009
  • Manufacturer
    Fisher and Paykel Healthcare Ltd

Manufacturer

Fisher and Paykel Healthcare Ltd